our mission
To help medical device companies navigate the unique challenges of developing and supplying medical devices
how we help medical device companies
our services
We offer a range of services allowing us to tailor the support we provide to meet our clients needs
Our range of services include:
- Quality management systems
- Regulatory compliance support including technical file writing, technical file updates, CE marking, UKCA marking, MDR, UDI and more.
- Sub-contract manufacture including clean room manufacture
- Testing
- EU authorized representative
- UK responsible person
certifications
13485
Our services are provided under a Quality Management System certified to
ISO 13485:2016