Robust designfor compliant products
We help you demonstrate that your medical deviceis compliant with MDR EU/2017/745and is able to get European market access.
Technical documentation serves to prove that a medical device meetsthe general safety and performance requirements and should be prepared in a clear, organised, readily searchable and unambiguous manner.
Our capabilities
- MDR EU/2017/745 (and previous directives)
- ISO 13485:2016
- Support in medical device technical documentation submission to Notified Bodies
- Benefit-risk analysis and risk management (ISO 14971)
- General Safety and Performance
- Requirements review
- Sample size procedure for product V&V testing
- Product labelling (ISO 15223)
- Design for manufacturing approach
- QMS procedures
- Regulatory Affairs consulting
- FDA remediation
- Integration with customer quality
- management system (QMS)
Experience
- Cardio polmunary medical devices
- Disposables and cannulae for circulatory support
- Extracorporeal Perfusion systems for hemodialysis
- Dental surgical equipment (piezoelectric devices, LED curing lamps, ultrasonic devices)
- Absorbable and non-absorbable sutures for ophtalmic, dental, plastic surgery and cardiac applications
- Thoracic catheters and wound drainage
- Disposables for anesthesia and rianimation