Medical consulting service

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

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Medical devices

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