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