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: |
| MDR II. |
Preparation of the Technical Documentation: |
| MDR III. |
Preparation of technical documentation on post-market surveillance: |
| MDR XIV. |
Preparation of the Clinical Evaluation: |
|
ISO 10993-1 ISO 10993-18 |
Preparation of the Biological Evaluation Report: |
|
EN 62366-1 |
Supporting of the Usability Engineering Process: |
|
MDR Art. 15 (9) IX., XI. A. ISO 13485 |
Perform audits: |
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: |
|
IVDR II. |
Preparation of the Technical Documentation: |
|
IVDR III. |
Preparation of technical documentation on post-market surveillance: |
|
IVDR XIII. |
Preparation of the Clinical Evaluation: |
|
EN 62366-1 |
Supporting of the Usability Engineering Process: |
|
IVDR Art. 10 (8) IX., XI. A. ISO 13485 |
Perform audits: |
Conformity assessment support - RoHS
|
Standard, legislation, guidance |
Description |
| RoHS Article 7. b) |
Support for internal production control procedure: |
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: |
| (MD, LVD, EMC, ATEX) |
Compilation of technical documentation in accordance with the relevant legislations: |