Medical  Device  &  QA  Consultancy

Medical Device Safety and Regulatory Affairs Consultancy

in the European Economic Area....

The Medical Device Directive (93/42/EEC) is applicable throughout the 29 (Twenty-Nine Countries) of the European Economic Area (EEA). The EEA is made up of the original 12 European Union member states + the old 7 EFTA countries (European Free Trade Area) + the new members who joined in 2004. These countries are;

Austria;  Belgium;  Denmark;  Finland;  France;  Germany;  Greece;  Holland (The Netherlands);  Iceland;  Republic of Ireland;  Italy;  Liechtenstein;  Luxemburg;  Norway; Portugal;  Spain;  Sweden;  Switzerland;  United Kingdom.

Since June 2004 the following countries have joined the European Union and as a result accept CE Marked medical products onto their markets;

  Cyprus:  Czech Republic; Estonia;  Hungary;  Latvia;  Lithuania;  Malta; Poland; Slovakia; Slovenia.

Since January 2007 the following countries joined the European Union;

Bulgaria; Rumania.

All EEA countries accept CE Marked Medical Devices onto their markets, even though they are not all European Union member states.

Summary of Services Offered

• Medical Device Directive strategies - All Classes of Device including Sterile.  Also Class I  "Self Certification Distance Strategy" - provision of a "Do It Yourself" manual, with full guidance.

• Post Sales Issues Vigilance, Adverse Incident Reporting, Post Market Feedback systems

• Design Control - Product Safety, New Product Development, Product Approvals

• Authorized Representative Services Two Levels of Service - "STANDARD" covering complete Regulatory requirements including all Post Sales Issues -  "PREMIUM" includes all "Standard" requirements plus   additionally a Tailor Made package to meet all your Pre Sales Requirements also.

• Own Brand (Private) Labeling Own Branding where you Label existing Products with your own Brand Name.

• Quality Management Systems Complete confidential support for any National, International or Global QMS, including ISO 9001:2000, ISO 9000:1994, EN 46000, FDA 21 CFR 820 QSR, ISO 13485

• Medical Device & QA Consultancy's Full range of Services

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