OUR SERVICES
Our objective is to accompany you on the scientific, technical, clinical and regulatory aspects of your medical devices
Regulatory Affairs :
- Regulatory strategy, including for new technologies
- Drafting of all or part of the technical file according to the MDR 2017/745 and IMDRF » Assembly and Technical Guide for IMDRF Table of Contents Submissions « , March 2019
- Support for the preparation of registration files including the CE marking file and their follow-up with the health authorities
- Drafting of the compliance with the General Safety and Performance Requirements according to Annex I of MDR 2017/745
- Drafting of user and patient instructions
- Impact analysis of changes and implementation strategy
- « Due diligence » regulatory
- Normative and regulatory watch
Quality :
- Pre-certification diagnostic audits
- Internal audits and preparation for audits and inspections
- Strategy and support for compliance with applicable standards (ISO13485, MDR 2017/745, MDSAP…)
- Support for the implementation of quality processes: regulatory monitoring, change management, risk management…
Production of mock-ups of packaging elements in compliance with your graphic charter and applicable regulations/standards (source files supplied).
- Labeling (design, integration of symbols (ISO 15223-1), …)
- IFU (design, layout, integration of translations, integration of symbols, etc.)
- Packaging (design, layout, integration of translations, integration of symbols, drawings, etc.)
Packaging project follow-up
Product development :
- Development strategy
- Definition of the specifications including the collection of information from users or health professionals.
- Traceability matrix (ISO13485, 21CFR820)
- Support for risk analysis (ISO14971) and fitness-for-use file (IEC 62366-1)
- Biological evaluation plan and report (ISO10993-1)
Clinical :
- Clinical strategy (clinical evaluation plan)
- REC
- Regulations (e.g. MDR 2017/745)
- Standards (e.g. risk management according to ISO 14971:2019)
- Clinical evaluation
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Product training
Market follow-up :
- Post-market follow-up (PMS/PMCF plan/report)
- Medical affairs studies (protocol writing, data exploitation for articles, poster, marketing use)
- Vigilance support (process)
- PSUR and RSPC writing
Medical Affairs :
- Professional relations and organization of networks
- Scientific and medical support to healthcare professionals
- Product strategy, definition and positioning
- Technical support for marketing
NEW EUROPEAN REGULATION
In this period of transition to the new European regulation for medical devices (MDR 2017/745), our focus is mainly regulatory to assist you in the final stages of compliance of your QMS and initiate the CE marking of your products (still under MDD 93/42/EC or under development) according to this new regulation.
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