Medical  Device  &  QA  Consultancy

QUALITY SYSTEMS.....THE WAY FORWARD FOR MEDICAL DEVICE MANUFACTURERS
Some formal means of controlling Documents, maintaining Records, reporting Incidents and verifying important Processes, (such as Purchasing & controlling subcontractors and Packaging & Labelling), underpins Regulatory Compliance requirements in all regions of the World.

The extent to which the above are implemented, is dependant primarily upon the perceived Risk of the medical products in question. Below are some of the Options open to Medical Device Manufacturers......

Your Options are wide and varied and the following are some of the questions you might have to consider..............?

 

ISO 9001:2000     OR ISO 13485:2003 ?

 

 ISO 13485:1996    OR   EN ISO 13485:2001 OR  ISO 13485:2003 ?

 

EN 46000:1996  OR   ISO 13485:1996  OR  ISO 13485:2001  ?

 

MDD 93/42/EEC Annex II  OR Annex  V  OR  Annex VI ?

 

Annex VII for Self Certification devices?

 

Sometimes a manufacturers Business Objectives may require to meet only the minimum regulatory requirements, in order to place his products on the market. Other times, he may also wish to benefit from Business Improvements. The table below endeavours to Illustrate the various compliance Options available with an indication as to whether the option is for minimal regulatory compliance or whether the Quality System will deliver Continuous Improvement of the business. 

 

All Compliance Strategies consist of both a Quality System / Quality Principles component and a Technical File.

 

 The Technical File addresses the Safety and Performance aspects, whilst the Quality System controls all tie Documentation and ensures processes deliver planned outcomes.

  

CLASS

 QUALITY SYSTEM TECHNICAL FILE COMMENTS
Class III ISO 9001:2000 or ISO 13485:2003     Annex II clause 4 Will give regulatory compliance and deliver business improvement
 Class IIb

 

 ISO 9001:2000 or ISO 13485:2003

 

     Annex II clause 3 [c]

Will give regulatory compliance and deliver business improvement.
Class IIa ISO 9001:2000 or ISO 13485:2003     Annex VII Will give regulatory compliance and deliver business improvement.
Class IM (Measuring) ISO 9001:2000 or ISO 13485:2003     Annex VII Will give regulatory compliance and deliver business improvement.
Class IS (Sterile)    ISO 9001:2000 or ISO 13485:2003     Annex VII Will give regulatory compliance and deliver business improvement.

THE FOLLOWING STRATEGIES WILL DELIVER ONLY REGULATORY COMPLIANCE
Class IIa Annex V Quality Plan focussing on Production.     Annex VII Sufficient to CE Mark your products.
Class IIa Annex VI Quality Plan concentrating on Final Inspection & Test     Annex VII Sufficient to CE Mark your products.
Class IM (Measuring) Quality Principles (GMP)     Annex VII Sufficient to CE Mark your products.
Class IS   (Sterile) Quality Principles (GMP) + Annex V to control the Sterile validation     Annex VII Sufficient to CE Mark your products.
Class I (on-Sterile & non-measuring) Quality Principles (GMP)     Annex VII This is the only Self Certification compliance route.
IN SUMMARY
A Notified Body must be appointed to audit both the Quality System and the Technical File aspects in all the above Strategies, except Class I non-Sterile & non-Measuring.

Where the Strategies outlined above which deliver only regulatory compliance are implemented, the Notified Body will only issue a Certificate authorising CE Marking of the Products, (ie: No ISO 9001 certificate will be issued).

Where the Strategy includes "Business Improvement", then the Notified body will issue an ISO 9001:2000 / ISO 13485:2003 Certificate, in addition to the Certificate authorising CE Marking of product.

EN 46001:1996 is still acceptable for some regulatory compliance in Europe, although limited.

ISO 13485:1996 is required for Canadian TPD registration.

In summary, we can assist accomplishment with any of the following; ISO 13485:1996 / EN ISO 13485:2001 / ISO 13485:2003 / MDD 93/42/EEC Annexes II; V; VI; VIII / IVD 98/79/EC - European Requirements, Canadian TPD Requirements, Australian TGA Requirements or FDA 21 CFR 820 QSR Requirements.............

Follow this Link for Technical File compilation guidance.

To request further information on any of the above issues, please complete this Feedback Form

To request a quotation on how we might assist you to accomplish any of the above Strategies, please complete the Form or e-mail: info@mdqa.co.uk