Medical  Device  &  QA  Consultancy

                   

Medical Device Safety, Regulatory Affairs Consultancy and Authorized Representative Services

in the European Economic Area....

The Medical Device Directive (93/42/EEC) and the In vitro Diagnostic Medical Device Directive (98/79/EC) is applicable throughout the 32 (Thirty One 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 and 2007. These countries are;

Austria;  Belgium;  Bulgaria; Cyprus:  Czech Republic; Denmark;  Estonia; Finland;  France; 

Germany; Greece;  Holland (The Netherlands);  Hungary;  Iceland;  Republic of Ireland;

Italy; Latvia;  Liechtenstein; Lithuania;  Luxemburg;  Malta; Norway; Poland;  Portugal;

Rumania;  Slovakia; Slovenia;  Spain; Sweden;  Switzerland;  Turkey;  United Kingdom.

 

Turkey is now signed up to the medical device directive regulations, even though they are not yet an official member of the EU       

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

 

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Medical Device Safety and Regulatory Affairs Consultancy

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.
  • 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


  

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