Facilitate the CE marking or the 510(k) process of your products
Are you in the process of developing a medical device or an in-vitro diagnostic medical device, you can speed up time to market by using the MDC services in the registration and approval process by:
Implement a Quality Management System
- Developing a regulatory strategy for the CE marking and 510(k) process
- Identifying the appropriate conformity assessment route
- Drawing up the Technical File or the DMR
- Establishing a Risk Management System
- Ensuring compliance with post-market vigilance requirements
- Liaising with regulatory authorities
- Performing Mock-inspections prior to a Notified Body audit or a Regulatory inspection by an authority,
MDC has extensive experience in developing and implementing Quality Management Systems (QMS) in accordance with ISO 9001, FDA QSR, EN/ISO 13485 and European medical device and in-vitro diagnostic directive requirements. The QMS is specifically designed for the needs of the individual company and the relevant level of regulatory requirement.
Keep on track with legislation
- Development and implementation of a QMS in accordance with ISO 9001, EN/ISO 13485, FDA QSR and other regulatory requirements
MDC can be your partner in regulatory issues and provide you with up-to-date knowledge about legislation and standards affecting your products.
- General consulting service concerning the EU-directives and FDA regulations
- Regular updating on legislation and harmonized standards