Increased complexity in the Medical Devices regulatory landscape is generating greater challenges that need to be addressed in order to maintain a competitive position in the market.
Asphalion’s solutions for Medical Devices cover a full range of technological segments, such as: Implants, Wound-care, Wearables, IVDs, Software as Medical Device, Substance based and Drug Device Combinations, among others.
Starting from a proof of concept, throughout the design & development process, product approvals and maintenance of the device in the market, Asphalion can provide you with full Regulatory and Quality Management System (QMS) support for a time to market optimisation by minimising regulatory setbacks since the very beginning.
These are some of the several solutions we offer:
- Support in development
- Support for CE certification & CE maintenance
- Support in definition and implementation of QMS
Have a look at the complete, more detailed list of solutions here:
For further requests, you can send us an email at: firstname.lastname@example.org