Kershaw Technology Services was established by Dr David Kershaw in 2010 to support the development of medical devices. The services offered are based on the experience gained from device development and manufacture as well as from their regulation. Since its foundation the company has been engaged in a wide range of projects.
Amongst these have been the following:
- Gap analysis of manufactures current systems to identify the regulations relevant to specific products
- Development of business processes to ensure compliance with relevant regulations
- Development of Device Technical Files.
- Identification and classification of borderline products.
- Creation of design and development documentation
- Creation of compliant Design and Development processes.
- Creation of compliant validation documentation.
- Development and implementation of compliant processes for the following
- Product Design and Development
- Design Validation and Verification
- Risk management
- Notifiable incidents
- Process Validation
- Test method validation
- Development of anti microbial product prototypes
- Project Management