Supporting companies new to the medical device sector
Providing long term solutions and support to companies new to the medical device industry by:
- One stop shop for quality and regulatory requirements
- Create ISO 13485 Quality Management System specifically for medical devices
- CE Marking, 510(k) and other worldwide Regulatory compliance
- Write/compile technical files or design dossiers for products
- Support from initial design to product launch and beyond
- Technical questions answered
- Advice on best practice & Industry standards
- Practical & realistic solutions
- Candidate screening for regulatory and quality positions
“
Having worked with High Edge for a number of years I have always found them helpful and willing to offer relevant advice to the situation we are working on. High Edge bring a fantastic mix of professionalism and personality making the issues we face seem less daunting and more manageable.
Neil Campbell - Managing Director, Inspiration Healthcare
”