AUTHORIZED REPRESENTATIVE SERVICES

Medical Device & QA Consultancy

TECHNICAL  AGREEMENT INFORMATION

EXPERIENCE and TRACK RECORD

Medical Device & QA Services is well placed to represent your best Regulatory Interests in an Honest and Professional Manner.......we have almost 30 years experience of the Medical Device Manufacturing Industry and over 2,500 hours experience auditing Medical Device Companies like yours, for their compliance with the Medical Device Directive (93/42/EEC), on behalf of European Notified Bodies.

SOME of the issues that our TECHNICAL AGREEMENT incorporates;

GENERAL POLICY and COMMITMENT

To represent all our Clients best interests, in an honest and professional manner, at all times.

To provide help and assistance to enable all our Clients to meet their Regulatory responsibilities effectively and at a minimum cost

To provide information and guidance on the latest interpretations and decisions of the Regulatory Bodies in Europe

To provide our Clients with the opportunity to benefit from Industry Best Practice, through our experience working with

European Notified Bodies, on a regular basis

To provide all the above, at a fair and reasonable cost.

To continuously Improve the Service that we provide

MEDICAL DEVICE & QA SERVICES responsibilities;

Liasing with your Notified body or Competent Authorities, on your behalf, as necessary

Registering the Your Company's Products with appropriate Competent Authorities

Participation in the reporting of Adverse Incidents to Competent Authorities, on behalf of the Your Company

Reporting back to the Your Company on issues affecting your current compliance, at regular intervals

Updates on the changing Regulatory and Quality Management System scene in Europe and the World, through the SEARCH ENGINE facility on our Home Page.

Assistance in the setting up of relevant feedback from Distributors and Sales Organisations, to enable Your Company to meet your Post Market Feedback and other MDD 93/42/EEC responsibilities .

Unlimited Technical Support in Post Sales Issues to help your Company meet it's Medical Device Directive responsibilities.

1 Hour support each month to assist with resolution of any Regulatory or Quality Management System issue

This One Hour Support is extended to 3 hours, at no extra cost to your company, if you have to Report an Incident or you become involved in a Product Recall.

Our commitment to give you TOTAL support extends to helping you to Close Out non-conformances raised by Notified body, if necessary, in Total Confidence of course.

Our Web Site also has a frequently updated Frequently Asked Questions (FAQ's), to further support our Customers and help them accomplish their Regulatory and Quality System objectives

For our Customers, the answer to almost any Regulatory or Quality System question is merely a telephone call or an e-mail away......

The MANUFACTURERS RESPONSIBILITIES;

Keep the Declaration of Conformity, including the Product Schedule, up to date and inform us of any changes.

Provide us with a copy of the draft Labelling including the Instructions for Use.

Ensure, with our help, that Complaint Handling, Adverse Incident Reporting (Vigilance), Post Market Feedback, Product Recall and Advisory Notice Issue and Significant Change Notification procedures are in place and meet current requirements.

Commitment to Retain Records and Documentation in line with the Medical Device Directives requirements (MDD 93/42/EEC Annexes II clause 6.1, Annex V clause 5.1 or Annex VII clause 2 as appropriate).

Commitment to make the Technical File available to Competent Authorities within seven (7) days of a request.

Implementation of a Post Market Feedback system, compliant with current Competent Authority and European Regulatory requirements.

Implementation of a Significant Change notification system, compliant with current Competent Authority requirements.

We will provide all the necessary help to enable your Company to meet the above requirements.

All the above issues are incorporated into a Technical Agreement which is presented in a clear and concise manner with no ambiguity.

To request an official Quotation

Thank you for visiting this Web Site. A more detailed Company Profile is available. If you require further information on any Medical Device compliance issue, please feel free to e-mail Bernard J. Tremaine at:

bernardt@mdqaconsultancy.co.uk

  Link back to HOME PAGE

Page of USEFUL LINKS to other Medical Device Web Sites