Experienced, Professional Support for Medical Device Manufacturers

We supply 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, sterilization 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