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Welcome to Medical Device & QA Consultancy / Services Web Site.... 

 Your ONE STOP Resource For Regulatory Compliance of Medical Devices & In Vitro Diagnostic Devices........

....Including Compliance with the Revised Medical Device Directive 2007/47/EC which is Mandatory from March 2010...............are you ready! ......more......

Authorized Representative

ABHI-Association of British Healthcare Industries

Company Profile

Competent Authorities

Conformance  Routes

Design Control

Design Dossier 

FDA 21 CFR 820

Hazard Evaluation

Links to Useful Sites 

ISO 13485 Assistance

ISO 9000 Assistance

IRCA (International Register of Certified Auditors)

MDA-Medical Device Agency

MHRA

Notified Body List (UK)

Own Brand Labeling 

Post Sales Issues 

Pre Market Notif ( 510(k)

 QSR (FDA) Regulation

Regulatory Affairs Issue

Retained Consultancy 

Review of Safety

Risk Analysis 

Safety of Medical Devic

Standards Advisory S

Technical File 

Track Record.

Medilink - Assistance to  Device Manufacturers

Turkey is now signed up to the medical device directive regulations, including Competent Authority requirements.

Therefore there are now 32 countries which will accept CE Marked Medical Devices and IVD Medical Devices....more.....

MEDICAL DEVICES - We offer a One Stop Source of the all help you will ever need, to ensure a successful Medical Device Compliance strategy [MDD 93/42/EEC], including In Vitro Diagnostic Medical Devices (IVD's in accordance with Directive 98/79/EC) and Quality Management Systems to ISO 13485:2003 / ISO 9001:2000 or ISO 13485:1996 for compliance with Canadian QMS Regulatory Requirements (up to end 2006)...............more......

HAZARD ANALYSIS and RISK MANAGEMENT  EN 14971............more...........

DESIGN CONTROL - Do you need assistance to Implement effective Design Control?...more...

COMPANY and PERSONAL PROFILE.....over 30 years in the Healthcare Industry and vast Auditing experience............more..... 

Temporary Link to other services........

QUALITY SYSTEMS -

We can also assist accomplishment with any of the following;

ISO 9001:2000 / ISO 13485:2003 (or ISO 13485:1996 / ISO 13485:2001 for Canada until end of 2006)  / MDD 93/42/EEC / IVD 98/79/EC - European Requirements, Canadian TPD Requirements, Australian TGA Requirements or FDA 21 CFR 820 QSR Requirements.......more......

ISO 13485 for manufacturers of medical devices........more......

ISO 9001:2000 to deliver customer satisfaction and business improvement.....more.....

AUTHORIZED REPRESENTATIVE Services for Medical Device manufacturers located outside Europe.

Help in choosing an Authorized Representative Service provider.

Further Information including our Policy

Changing to an Alternative Authorized Representative Service Provider

SUMMARY of BENEFITS of our AR Service

What is a medical device....more..........?

What is an IVD (In Vitro Diagnostic Medical Device)....more....

How do I correctly Classify my products....more....?

EXPERT WITNESS....Do you need an Expert Witness who is well versed in a wide range of medical equipment and associated issues.....more........?

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