MdQaConsultancy.co.uk
Title
Medical Device Regulatory Compliance
Description
ORIGIN: Medical Device & QA Consultancy was formed in 1994, to assist Manufacturers of Medical Devices to accomplish their European and/or FDA Regulatory compliance. Through arrangements with our Associate Partners, both in the USA and Europe, we are able to offer a truly all-encompassing Service to the Medical Device Manufacturing Industry .
Bernard Tremaine also has substantial experience in Reviewing Design Dossiers of Active Medical Devices, on behalf of European Notified Bodies, to assess compliance with the Design Control requirements of Annex II Clause 4 of the Medical Device Directive 93/42/EEC.
CE Marking of all Classes of Medical Device or IVD , with help ranging from Full Maximum Assistance to a Minimum Cost Class I Strategy .
Languages
English
Additional Information
Related Domains
- Authorized
- Authorized Representative
- Business
- Ce Marking
- Consultants
- Consulting
- Design Control
- Device Safety
- Devices
- Diagnostic
- Directive 93
- Eec
- En 46001
- En 46002
- Hazard Analysis
- Healthcare
- Iso 13485
- Medical
- Medical Device Consultant
- Medical Devices
- Quality Management Systems
- Representative
- Risk Management
- Training
- Vitro
- 42
- EEC
- In