Experienced, professional support for medical device manufacturers
Supplying Regulatory and Quality solutions to the medical device industry:
- CE Marking, 510(k) and other worldwide Regulatory compliance
- Specific projects such as technical file authoring, sterilisation validation, internal auditing
- Skills gaps
- Knowledge gaps
- Supporting growth into new markets
- Supporting growth with new product lines
- Specialist fields (microbiology, sterilisation, clinical evaluations and biological reviews)
- Interim Cover (Maternity, sickness, urgent need)
- Resolution of Auditor findings
- Global coverage - including USA, Canada, Australia, Europe and others
- Candidate screening for regulatory and quality positions
“
Very knowledgeable on all matters regarding quality systems both ISO 13485 and the US QSRs. In addition excellent advice on ethylene oxide sterilisation issues and general medical device regulatory matters. Very flexible and adapted easily to the Zimmer working environment and style. I would not hesitate to recommend High Edge Consulting.
Suzan Burnstead - Director Regulatory Affairs & compliance Europe, Zimmer
”