Regulatory

Achieving regulation is a vital stage to getting your medical device on the market, and maintaining ongoing compliance. Lack of resource, deadlines creeping forward, specialist projects and knowledge gaps are common hurdles that need to be overcome.

MEDDEV CONSULT can take the commercial pressure of compliance off your hands and allow you to focus on preparing your product to go to market. Whether it is Europe, USA, Canada and beyond, the MEDDEV CONSULT team can help delivering a smooth route to market. Our flexible approach and experience means that whatever the device or statutory requirements, our team of consultants can parachute in to get your project moving.

• CE Marking
• 510(k) & PMAs
• 93/42/EEC Medical Device Directive
• 98/79/EC In Vitro Diagnostic Medical Device Directive
• 90/385/EEC Active Implantable Medical Device Directive
• Product Technical Files
• Design Dossiers
• Risk Management
• Clinical Evaluation
• Biocompatibility
• Auditing to MDDs
• Country Registrations