Providing you with the best results
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About DM Smart Engineering GmbH

We, at DM Smart Engineering, are a team of multilingual Engineers, working across Europe, Asia, Middle East, America and Africa, in the Invitro Diagnostik Industry. We are Experts in the fields of:

Quality Assurance

At DM Smart Engineering, we provide you full guidance and support in Quality Assurance.

…for the best results!

  • compliance Activities to achieve the implementation and maintenance of an effective Quality System
  • Identification and Implementation of Process Improvements
  • Leadership in Performance and Documentation of Risk management as required by ISO 14971
  • Leadership and documentation in the performance of DFMEA and PFMEA
  • Support in Resolution of Quality Issues in Manufacturing
  • Monitoring the Operational Quality Assurance Procedures and CAPA
  • Planning and Implementation of Internal Audits and Inspections
  • Evaluation and Approval of Deliverables and Related tools to ensure GMP Compliance
  • SOPs, Work instructions and Forms -Writing, Reviewing, Approving
  • Activities Providing, Inspecting, Auditing
  • Management of all internal and external audits to ensure a successful outcome
  • Competence in Regulatory Requirements and Industry Trends for Medical Device Quality Systems (e.g. ISO 13485, 21 CFR 820)
  • Quality Assurance Improvement Projects
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support in Quality Assurance.

…for the best results!

  • compliance Activities to achieve the implementation and maintenance of an effective Quality System
  • Identification and Implementation of Process Improvements
  • Leadership in Performance and Documentation of Risk management as required by ISO 14971
  • Leadership and documentation in the performance of DFMEA and PFMEA
  • Support in Resolution of Quality Issues in Manufacturing
  • Monitoring the Operational Quality Assurance Procedures and CAPA
  • Planning and Implementation of Internal Audits and Inspections
  • Evaluation and Approval of Deliverables and Related tools to ensure GMP Compliance
  • SOPs, Work instructions and Forms -Writing, Reviewing, Approving
  • Activities Providing, Inspecting, Auditing
  • Management of all internal and external audits to ensure a successful outcome
  • Competence in Regulatory Requirements and Industry Trends for Medical Device Quality Systems (e.g. ISO 13485, 21 CFR 820)
  • Quality Assurance Improvement Projects
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Product Development Guidance

At DM Smart Engineering, we provide you full guidance and support in your Medical Device Product Development.

We advise you on the applicable norms and standards and we guide you at every step of the development process documentation…

…for the best results!

  • Product Development Guidance, applied individually to meet your company’s needs
  • Building the Perfect Team for your Project or Guide the existing team to success
  • R&D Project Management
  • Strong Project Planning and Budgeting
  • Leading the technical documentation of the product for CE-Marking and 510(k) submissions
  • Defining the required product deliverables for certification
  • Determine the product classification & list of applicable standards
  • Formulation Usability Specification, Test Plan and working on test report
  • Formulation the intended uses and User Requirement Specifications
  • Formulation the product Validation Plan and Methods
  • Leading the System Requirement specification
  • Hardware and Software Requirement Specification
  • Leading the preparation to Product testing (60601 etc…)
  • Leading Risk Management File (Risk Management Plan, Risk Analysis, Risk Management Report)
  • Leading the DFMEA
  • Leading the writing of technical documentation
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support in your Medical Device Product Development.

We advise you on the applicable norms and standards and we guide you at every step of the development process documentation…

…for the best results!

  • Product Development Guidance, applied individually to meet your company’s needs
  • Building the Perfect Team for your Project or Guide the existing team to success
  • R&D Project Management
  • Strong Project Planning and Budgeting
  • Leading the technical documentation of the product for CE-Marking and 510(k) submissions
  • Defining the required product deliverables for certification
  • Determine the product classification & list of applicable standards
  • Formulation Usability Specification, Test Plan and working on test report
  • Formulation the intended uses and User Requirement Specifications
  • Formulation the product Validation Plan and Methods
  • Leading the System Requirement specification
  • Hardware and Software Requirement Specification
  • Leading the preparation to Product testing (60601 etc…)
  • Leading Risk Management File (Risk Management Plan, Risk Analysis, Risk Management Report)
  • Leading the DFMEA
  • Leading the writing of technical documentation
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

DHF Remediation

At DM Smart Engineering, we provide you full guidance and support in DHF Remediation activities.

…for the best results!

  • DHF Remediation Project Management Plan
  • DHF Gap Assessment & Improvement Plan
  • DHF Remediation Activities Structure
  • Formal Design Control Processes Review
  • Root Cause Investigations and Remediation Action Plan
  • Leadership and full support in Update of Technical and Design Documentation
  • Technical Writing-Reports and Technical Justification
  • Change Controls Management
  • Onsite and Offsite Support and Coordination
  • Full support for DHF compliance with FDA 21 CFR Part 820 and ISO 13485
  • Full Support for FDA and Notified Body Audit preparation
  • Full Support for 510 (k) submission and CE-Conformity Assessment
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support in DHF Remediation activities.

…for the best results!

  • DHF Remediation Project Management Plan
  • DHF Gap Assessment & Improvement Plan
  • DHF Remediation Activities Structure
  • Formal Design Control Processes Review
  • Root Cause Investigations and Remediation Action Plan
  • Leadership and full support in Update of Technical and Design Documentation
  • Technical Writing-Reports and Technical Justification
  • Change Controls Management
  • Onsite and Offsite Support and Coordination
  • Full support for DHF compliance with FDA 21 CFR Part 820 and ISO 13485
  • Full Support for FDA and Notified Body Audit preparation
  • Full Support for 510 (k) submission and CE-Conformity Assessment
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

CAPA & Nonconformity

At DM Smart Engineering, we provide you full guidance and support for all CAPA and Nonconformity activities.

…for the best results!

  • Support and Guidance in All issues regarding CAPA and Nonconformity in Medical Device
  • CAPA compliance metrics & Collection of objective evidence
  • Fast and Thorough Process of Assigning Non-Conformances, Investigations and Corrective Actions
  • Fast documentation of non-conformances & Corrective Action for best results
  • Proactive Action for fast and best results & Tracking Report Management
  • Implementation of the standardized procedures, processes and systems for CAPA
  • Implementation of Measures to Monitor the efficiency of the CAPA System.
  • Overview and Monitoring of Supplier’s CAPAs
  • Performance of CAPA Data analysis to identify areas for improvement
  • Ensure the Best Results & Time Management
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support for all CAPA and Nonconformity activities.

…for the best results!

  • Support and Guidance in All issues regarding CAPA and Nonconformity in Medical Device
  • CAPA compliance metrics & Collection of objective evidence
  • Fast and Thorough Process of Assigning Non-Conformances, Investigations and Corrective Actions
  • Fast documentation of non-conformances & Corrective Action for best results
  • Proactive Action for fast and best results & Tracking Report Management
  • Implementation of the standardized procedures, processes and systems for CAPA
  • Implementation of Measures to Monitor the efficiency of the CAPA System.
  • Overview and Monitoring of Supplier’s CAPAs
  • Performance of CAPA Data analysis to identify areas for improvement
  • Ensure the Best Results & Time Management
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Project Management

At DM Smart Engineering, we provide you full guidance and support for Project Management in the Invitro Diagnostik Industry…

…for the best results!

  • Management of cross-functional teams of employees
  • Responsibility for every part of the process
  • Design, Development and Implementation of complex medical Device Projects
  • Goal-Orientation and Team-Support to provide you with the best results
  • Leadership
  • Guidance and support of all interdisciplinary Project teams involved
  • Plan, Control and Monitor of the Project
  • Risk Management
  • Coordination of all processes
  • Networking and Cooperation with all industry associations
  • Cooperation with the Quality Teams for the best results
  • Organisation and Allocation of resources for the best results
  • All project related documents meet internal routines and requirements
  • Leadership and Management
  • Work closely with all team members, ensuring to develop each team member’s strengths and cooperation for the best results
  • Strategic Guidance at every step of the project
  • Extensive consulting (business flexibility, speed to market, compliance and cost efficiency)
  • Ensure availability of skills and resources within the organisation for the best results
  • Coordination with international colleagues and external partners to accomplish driven development efforts and product support tasks
  • Identify, initiate and lead the cooperation with international external partners on every level
  • Find future options in close collaboration with product management to develop a sustainable longstanding product roadmap
  • Budget Control
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support for Project Management in the Invitro Diagnostik Industry…

…for the best results!

  • Management of cross-functional teams of employees
  • Responsibility for every part of the process
  • Design, Development and Implementation of complex medical Device Projects
  • Goal-Orientation and Team-Support to provide you with the best results
  • Leadership
  • Guidance and support of all interdisciplinary Project teams involved
  • Plan, Control and Monitor of the Project
  • Risk Management
  • Coordination of all processes
  • Networking and Cooperation with all industry associations
  • Cooperation with the Quality Teams for the best results
  • Organisation and Allocation of resources for the best results
  • All project related documents meet internal routines and requirements
  • Leadership and Management
  • Work closely with all team members, ensuring to develop each team member’s strengths and cooperation for the best results
  • Strategic Guidance at every step of the project
  • Extensive consulting (business flexibility, speed to market, compliance and cost efficiency)
  • Ensure availability of skills and resources within the organisation for the best results
  • Coordination with international colleagues and external partners to accomplish driven development efforts and product support tasks
  • Identify, initiate and lead the cooperation with international external partners on every level
  • Find future options in close collaboration with product management to develop a sustainable longstanding product roadmap
  • Budget Control
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Regulatory Affairs

At DM Smart Engineering, we provide you full guidance and support for your Medical Device Equipment RA&QA needs.

…for the best results!

  • Guarantee compliance to the applicable regulatory and corporate standards and requirements
  • Research, prepare, construct and submit Documentation for the EU, US and global regulatory product submissions
  • Update data for the applicable laws, regulations and Industry standards
  • Collaborate with R&D and manufacturing functions in various business units to define technical files and to guarantee compliance in all development and manufacturing activities such as verification and validation plans
  • Collaborate with application engineers and your customers to define regulatory requirements, strategies and plans, as well as technical documentations in your company’s projects
  • Update application engineers and local quality manager on changes in regulatory requirements relevant for technical file
  • Participate in manufacturing audits (regulatory authorities, customers and internal)
  • Support for audits from regulatory authorities, customers and internal
  • Monitoring and tracking of International Product Registrations
  • Lead Efficiency Projects and other Special Assignments
  • Interface with OEMs to collect specific registration information
  • Develop and maintain procedures/work instructions for International Product Registrations
  • Monitor and collect impact assessments of product changes
  • Provide regulatory guidance during the entire life cycle of your business‘ medical devices
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support for your Medical Device Equipment RA&QA needs.

…for the best results!

  • Guarantee compliance to the applicable regulatory and corporate standards and requirements
  • Research, prepare, construct and submit Documentation for the EU, US and global regulatory product submissions
  • Update data for the applicable laws, regulations and Industry standards
  • Collaborate with R&D and manufacturing functions in various business units to define technical files and to guarantee compliance in all development and manufacturing activities such as verification and validation plans
  • Collaborate with application engineers and your customers to define regulatory requirements, strategies and plans, as well as technical documentations in your company’s projects
  • Update application engineers and local quality manager on changes in regulatory requirements relevant for technical file
  • Participate in manufacturing audits (regulatory authorities, customers and internal)
  • Support for audits from regulatory authorities, customers and internal
  • Monitoring and tracking of International Product Registrations
  • Lead Efficiency Projects and other Special Assignments
  • Interface with OEMs to collect specific registration information
  • Develop and maintain procedures/work instructions for International Product Registrations
  • Monitor and collect impact assessments of product changes
  • Provide regulatory guidance during the entire life cycle of your business‘ medical devices
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Qualification and Validation

At DM Smart Engineering, we provide you full guidance and support for your Medical Device Equipment Qualification and Process Validation.

…for the best results!

  • Transfer and validation of your company`s products
  • Leadership in equipment qualification (Design Qualification, Equipment-IQ, Equipment-OQ, Equipment-PQ)
  • Lead Project Engineering staff through development and execution of validation plans
  • Preparation/Evaluation of change controls to ensure qualification and validation stays constant, providing you with the best results
  • Writing, Control and Report of all Protocols
  • Identify critical parameter controls based upon potential impact on product quality attributes
  • Ensure everything is performed in accordance with applicable regulations, industry guidelines and practices, approved site and procedures.
  • Identification and Investigation of unusual or unexpected events, data or sources of variation regarding the development and performance of validation and qualification
  • Recommendation of proactive and corrective actions
  • Coordination of assigned qualification projects with other departments
  • Performance and Documentation of risk assessments for computerised systems, equipment, processes and products.
  • Supervision and training for validation engineering staff (review of draft protocols, oversight of data collection, review/approval of raw data and assembled qualification packages)
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support for your Medical Device Equipment Qualification and Process Validation.

…for the best results!

  • Transfer and validation of your company`s products
  • Leadership in equipment qualification (Design Qualification, Equipment-IQ, Equipment-OQ, Equipment-PQ)
  • Lead Project Engineering staff through development and execution of validation plans
  • Preparation/Evaluation of change controls to ensure qualification and validation stays constant, providing you with the best results
  • Writing, Control and Report of all Protocols
  • Identify critical parameter controls based upon potential impact on product quality attributes
  • Ensure everything is performed in accordance with applicable regulations, industry guidelines and practices, approved site and procedures.
  • Identification and Investigation of unusual or unexpected events, data or sources of variation regarding the development and performance of validation and qualification
  • Recommendation of proactive and corrective actions
  • Coordination of assigned qualification projects with other departments
  • Performance and Documentation of risk assessments for computerised systems, equipment, processes and products.
  • Supervision and training for validation engineering staff (review of draft protocols, oversight of data collection, review/approval of raw data and assembled qualification packages)
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Manufacturing Support for compliance with GMP requirements

At DM Smart Engineering, we provide you full guidance and support in the Medical Device Manufacturing Process…

…for the best results!

  • Guidance and support for product manufacturing transfer documentation
  • Lead the implementation of product specifications into the manufacturing process
  • Monitoring of timelines and project deliverables to achieve approved project plans for manufacturing process development
  • Lead the implementation of packaging design
  • Process and equipment expertise and support
  • Equipment Qualification
  • Perform and document the PFMEA
  • Process Validation
  • Process support on Manufacturing Technical Issues documentation
  • Writing of the Manufacturing SOPs, Work Instructions and Forms
  • Support for GMP Audits from FDA or Notified Body
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support in the Medical Device Manufacturing Process…

…for the best results!

  • Guidance and support for product manufacturing transfer documentation
  • Lead the implementation of product specifications into the manufacturing process
  • Monitoring of timelines and project deliverables to achieve approved project plans for manufacturing process development
  • Lead the implementation of packaging design
  • Process and equipment expertise and support
  • Equipment Qualification
  • Perform and document the PFMEA
  • Process Validation
  • Process support on Manufacturing Technical Issues documentation
  • Writing of the Manufacturing SOPs, Work Instructions and Forms
  • Support for GMP Audits from FDA or Notified Body
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Risk Management and FMEAs (DFMEA, PFMEA)

At DM Smart Engineering, we provide you full guidance and support for your Risk Management and FMEAs activities.

…for the best results!

  • Guaranteeing that your process is in full compliance with ISO 14971 requirements
  • Leading the Risk Management activities in R&D/ Manufacturing project
  • Writing Risk Management Plans and reports
  • Performing Risk analysis and writing Risk Analysis Reports (we provide templates and full guidance)
  • Performing and documenting DFMEA and PFMEA (we provide templates and full guidance)
  • Make sure the input is transferred to the R&D / Manufacturing process
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support for your Risk Management and FMEAs activities.

…for the best results!

  • Guaranteeing that your process is in full compliance with ISO 14971 requirements
  • Leading the Risk Management activities in R&D/ Manufacturing project
  • Writing Risk Management Plans and reports
  • Performing Risk analysis and writing Risk Analysis Reports (we provide templates and full guidance)
  • Performing and documenting DFMEA and PFMEA (we provide templates and full guidance)
  • Make sure the input is transferred to the R&D / Manufacturing process
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

QMS and GMP Auditing

At DM Smart Engineering, we provide you full guidance and support for QMS and GMP Audits in Medical Device…

…for the best results!

  • FDA and Notified Body audit preparation (Audit clean-up and readiness)
  • Audit Preparation guidance for your R&D process, Manufacturing process, RA/QA process and other processes in scope of the audit.
  • We Perform audits for you at your facilities
  • Leading and Conducting Audits (Agendas, Reports, Performance of follow-up actions)
  • Compiling of Objective Evidence
  • Writing Audit reports
  • Investigation of all Compliance issues (noted during audits and inspections or otherwise observed and detected)
  • GMP Management
  • Documentation and Coordination of all Audit Schedules
  • Identification of Risks in cases of delay for the best results
  • Management and Update of Information regarding international GMP regulations
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support for QMS and GMP Audits in Medical Device…

…for the best results!

  • FDA and Notified Body audit preparation (Audit clean-up and readiness)
  • Audit Preparation guidance for your R&D process, Manufacturing process, RA/QA process and other processes in scope of the audit.
  • We Perform audits for you at your facilities
  • Leading and Conducting Audits (Agendas, Reports, Performance of follow-up actions)
  • Compiling of Objective Evidence
  • Writing Audit reports
  • Investigation of all Compliance issues (noted during audits and inspections or otherwise observed and detected)
  • GMP Management
  • Documentation and Coordination of all Audit Schedules
  • Identification of Risks in cases of delay for the best results
  • Management and Update of Information regarding international GMP regulations
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Project Management UDI

At DM Smart Engineering, we provide you full guidance and support for UDI implementation of your medical device product class I, II and III

We provide you guidance and support in:

  • Identification of processes in scope of UDI in your QMS
  • Project planning for UDI implementation of your Class I, II and III products
  • GS1, DI, PI, AIDC, UDID
  • UDI implementation of your packaging
  • leading your R&D through the DPM (direct part marking)
  • efficient management of your ECRs (Engineering Change Requests)
  • We lead the UDI implementation in your manufacturing and support with update of your manufacturing processes and procedures (SOPs, Work instructions and Forms -Writing, Reviewing, Approving)
  • We help you achieve an UDI compliant and effective Quality System
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

At DM Smart Engineering, we provide you full guidance and support for UDI implementation of your medical device product class I, II and III

We provide you guidance and support in:

  • Identification of processes in scope of UDI in your QMS
  • Project planning for UDI implementation of your Class I, II and III products
  • GS1, DI, PI, AIDC, UDID
  • UDI implementation of your packaging
  • leading your R&D through the DPM (direct part marking)
  • efficient management of your ECRs (Engineering Change Requests)
  • We lead the UDI implementation in your manufacturing and support with update of your manufacturing processes and procedures (SOPs, Work instructions and Forms -Writing, Reviewing, Approving)
  • We help you achieve an UDI compliant and effective Quality System
We provide support across Europe, Asia, Middle East, America and Africa in: Quality Assurance, Qualification and Validation, Manufacturing, CAPA & Noncompliance, R & D Project Development, DHF Remediation, Risk Management, QMS & GMP Auditing, Regulatory Affairs, Project Management UDI. We advise you in: Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304, IEC 60601, IEC 62366

Let's Get In Touch!

DM Smart Engineering GmbH
Myrtenweg 41
7000 Chur
Switzerland
+41779657552
info{at}dmsmart.ch