Kershaw Technology Services is able to offer both consultancy and contract regulatory support to manufactures and product developers in their compliance with the requirements of the regulations governing the sale of medical devices.
The services include;
- Preparation of Technical file and design dossier documentation
- Preparation design and development documentation
- Use of subcontractors
- Preparation of Risk Management documentation
- Device classification and route to conformity (CE marking)
- Identification and compliance with relevant directives and regulations
- Development of business procedures to ensure compliance with current directives for manufacturers and distributor/importers
- Borderline products at the interface between the Cosmetic/Devices/Pharmaceutical regulations.