Countries have differing definitions of a Medical Device but in general terms they all agree that in principle a medical device has a Medical intent, but achieves its main action without having to cause an imbalance or change in the biochemistry of the human body. Growth in the Medical Device Sector has been significant.
Regulatory practices are moving strongly to harmonize but, there are still specific differences in approach and the requirements to support claims in three strategic areas – USA, EU and China. Careful planning needs to be in place from the concept for most medical devices, especially if they are to be commercialized in all territories.
Verta Life Sciences provides management of product development including all elements required for the Design File plus assistance in the strategic planning and implementation of the design, clinical support and regulatory filing of devices.
- Sourcing and Selecting a Notified Body for EU Compliance
- Auditing and ensuring Quality Systems meet FDA 21CFR 820 and /or ISO 13485
- Designing Development Programs to meet Strategic Commercial Requirements
- Project Management
- Clinical Study planning and Support
- Stability Study protocols and management
- Technical Support in Design and Manufacturing
- Leading Risk Assessments of the device design and Manufacturing Practices ISO 14971