Medical devices are regulated in Europe by the directives 93/42/EC (medical devices) and 98/79/EC (IVD), and in the U.S. through federal law (21 CFR 800-900).
In order to comply with these regulations we will support your business in these areas:
- Design, Implementation and Optimization of a compliant Quality Management System (ISO 13485 and FDA QSR)
- Establishing Design Controls for ISO 13485 and FDA Compliance
- Risk Management (ISO 14971) Assistance and Implementation
- Software Development and Validation (IEC 62304)
- Usability Engineering (IEC 62366)
- Validation of Manufacturing Processes and Qualification of Equipment and Systems
- FDA 510(k) and PMA submissions
- European CE marking
- Preparation and support for inspection by Notified Bodies or FDA
Our extensive experience will assist and support your company in a faster introduction of your product into the US or EU market, and have your company and product comply with FDA or EU regulations, within an economically feasible project.