Providing Regulatory and Quality compliance solutions to the medical device industry
High Edge Consulting can provide you with assistance and consultancy in the following areas:
UK/EU Regulatory Compliance
- 93/42/EEC Medical Device Directive
- 98/79/EC In Vitro Diagnostic Medical Devices Directive
- 90/385/EEC Active Implantable Medical Devices Directive.
- Technical Files & Design Dossiers
- Risk Management
- Clinical Reviews
- Biological Evaluations
- Country Registrations
- Auditing
Worldwide Compliance
- Includes, amongst others,
- USA - 510K & PMAs
- Canada
- Australia
- New Zealand
- Japan
Sterilisation
- EtO specialisms
- Gamma & e-beam
- Protocol authoring and/or review
- VD max, dose mapping, dose auditing
- Re validation
- Interpretation of results
- Justifications
Microbiology & Contamination control
- Results interpretation & trending
- Microbiology
- Cleanroom audits
- Justifications
Interim Support
- Interim Regulatory Manager
- Interim RA support
- Special projects
- Temporary contracts
- Part time contracts
- On going support
“
We were faced with a challenging validation project whish required some 'out of the box' thinking and external resources. This is where High Edge came in. What impressed us most was that our High Edge Consultant was prepared to think laterally while still holding true to all the applicable regulations and standards. The result was that we achieved regulatory approval for our new product on target and on budget.
Chris Brotherston, Regulatory Compliance Manager, Biosil Ltd
”
