Project initiation
- • Medical device justification, borderline
- assessments, product classification
- according to new Medical Device Regulation
- (MDR) and In Vitro Device Regulation (IVDR)
Regulatory advice
- • Scientific and strategic advice
- • Selection of notified bodies and competent
- authorities
Market entry strategies
- • Market analysis
- • Building up marketing and sales
CE Marking
- • Product conformity assessment
- • Gap Analysis and Update of existing Technical
- Documentation to the new Medical Device
- Regulation (MDR) and In Vitro Device Regulation
- (IVDR)
- • Compilation of Technical Documentation
- • Establishment of an appropriate Post Marketing
- Surveillance and Vigilance System
Project development
- • Project management
- • Proof of product quality
- • Data base searches, retrieval and evaluation
- of literature
- • Data gap analysis
- • Initiation and monitoring of safety studies
- • Biocompatibility evaluation according to
- EN ISO 10993
- • Analysis of the requirements set by the
- competent national authority and the
- Notified Body (NB)
- • Design and analysis of the performance
- evaluation
- • Preparation, up-dating and maintenance of
- Clinical Evaluation Report according to
- MEDDEV 2.7/1 rev. 4
- • Establishment, up-dating and maintenance of a
- Quality Management system according to EN ISO
- 13485 as well as a Risk Management system
- according to EN ISO 14971
- • Support in audit preparation and accompaniment
- through audits
Restriction on PFAS – next steps
