Medical devices

Consulting

Compliance with the regulation of medical devices poses an increasingly difficult task for economic operators. In order to reduce the burden on economic operators, we provide full support for the CE marking of medical devices (MDR & IVDR), from regulatory strategy to post-market surveillance.

 

Design and development of medical devices

Standard, legislation, guidance

Description

-

Product qualification support:

• applicable legislation

• definition of relevant categories / classes

MDR 10. (9) a)

Preparation of strategy for regulatory compliance:

• key players in the target market

• conformity assessment procedure

• the content of required documentation

• applicable standards and guidances

MDR I.

Preparation of test plan:

identification of tests to verify the general safety and performancerequirements of MDR Annex I.

EN 60601-1

EN 61010-2-101

Technical advice for the safe, standard design of devices

 

Cybersecurity

Standard, legislation, guidance

Description

AAMI TIR57 Prepare / support the Risk Management File based on Cybersecurity
AAMI TIR57 Provide expert review of the acceptability of all residual risks for Cybersecurity
- Monitoring the state-of-the-art level of Cybersecurity and reporting regularly
MDR I. Support and review the Information for Use based on Cybersecurity

EN 60601-1

EN 62304

IEC 82304-1

EN 62304

Change or create design and development procedures for Cyber Security

EN 62304

(IEC 62304)

Evaluation of Cyber Security aspects of software requirements:

• software architecture security analysis

• safety review of risk analysis

IEC/TR 60601-4-5

(IEC 62443-4-2)

Safety aspects of medical devices, support for safety level classification

ISO/IEC 27001

ISO/IEC 27002

Development and certification support of Information Security Management System

 

Conformity assessment support - MDR

Standard, legislation, guidance

Description

MDR Art. 29. 31. Support the registration of medical devices and economic operators (EUDAMED, NOR)
MDR Art. 27.VI. B. UDI design support
MDR Art. 10 (9)IX., XI. A.ISO 13485

Implementation of quality management system:
• preparation of documentation
• introductory education
• internal audit
• management review

MDR II.

Preparation of the Technical Documentation:
• device description
• information to be supplied by the manufacturer
• design and manufacturing information
• general safety and performance requirements checklist
• benefit-risk analysis and risk management
• product verification and validation support

MDR III.

Preparation of technical documentation on post-market surveillance:
• post-market surveillance plan
• Periodic safety update report
• post-market surveillance report

MDR XIV.

Preparation of the Clinical Evaluation:
• Clinical evaluation plan
• Clinical evaluation report
• Post Market Clinical Follow-up (PMCF) plan
• Post Market Clinical Follow-up (PMCF) report

ISO 10993-1

ISO 10993-18

Preparation of the Biological Evaluation Report:
• preparation of the biological evaluation strategy
• characterization of materials
• selection of studies or justification for omitting studies
• toxicological risk assessment
• summary evaluation of biocompatibility

EN 62366-1

Supporting of the Usability Engineering Process:
• compilation of the Usability Engineering File
• associated risk evaluation

MDR Art. 15 (9) IX., XI. A.

ISO 13485

Perform audits:
• CE (MDR) internal audit
• ISO 13485 internal audit
• supplier audit

 

Conformity assessment support - IVDR

Standard, legislation, guidance

Description

IVDR Art. 26. 28. Support the registration of medical devices and economic operators(EUDAMED, NOR)
IVDR Art. 24. VI. B. UDI design support

IVDR Art. 10 (8) IX., XI. A.

ISO 13485

Implementation of quality management system:
• preparation of documentation
• introductory education
• internal audit
• management review

IVDR II.

Preparation of the Technical Documentation:
• device description
• information to be supplied by the manufacturer
• design and manufacturing information
• general safety and performance requirements checklist
• benefit-risk analysis and risk management
• product verification and validation support

IVDR III.

Preparation of technical documentation on post-market surveillance:
• post-market surveillance plan
• periodic safety update report
• post-market surveillance report

IVDR XIII.

Preparation of the Clinical Evaluation:
• Clinical evaluation plan
• Clinical evaluation report
• Post Market Clinical Follow-up (PMCF) plan
• Post Market Clinical Follow-up (PMCF) report

EN 62366-1

Supporting of the Usability Engineering Process:
• compilation of the Usability Engineering File
• associated risk evaluation

IVDR Art. 10 (8) IX., XI. A.

ISO 13485

Perform audits:
• CE (IVDRMDR) internal audit
• ISO 13485 internal audit
• supplier audit

 

Conformity assessment support - RoHS

Standard, legislation, guidance

Description

RoHS Article 7. b)

Support for internal production control procedure:
• development of technical documentation
• supplementing the quality management system with RoHSrequirements

 

Conformity assessment support – production equipment (machines)

Standard, legislation, guidance

Description

RoHS Article 7. b)

Defining the requirements for the placing on the market or putting intoservice of production equipment:
• legislations
• harmonized standards
• conformity assessment procedure
• manufacturers or operator tasks

(MD, LVD, EMC, ATEX)

Compilation of technical documentation in accordance with the relevant legislations:
• list of applicable harmonized and other standards
• risk evaluation documentation
• drawings, wiring diagrams
• user documentation
• EU declaration of conformity

 

Contact