Medical  Device   &  QA  Consultancy

QUALITY MANAGEMENT SYSTEMS (QMS)

What Conformance Routes are available? 

What happens to EN 46000 now that the "new" version of ISO 9001 was published in December 2000?

How long can I continue to use EN 46001/2/3?

What are the differences between ISO 13485 and EN 46001/2/3?

How does ISO 13485 fit into a Medical Device compliance picture now?

Are the Clause numbers of  ISO 13485 the same as  EN 46001/2/3?

What are the future plans for ISO 9001:2000,  & what should I do to ensure longer term compliance term?

Back to Top

GENERAL ISSUES

Are all medical devices subject to the regulations in Europe?

Currently being revised

Back to Top

TECHNICAL FILE ISSUES

Currently being revised

Back to Top

IEC 601 SERIES of STANDARDS

What are the Standards that comprise the IEC 601 Series?

How do I comply with IEC 601-1-4?

Back to Top

RISK MANAGEMENT

What standards apply?

Back to Top

INCIDENT REPORTING, PRODUCT RECALL and ADVISORY NOTICE ISSUE

What type of Systematic Recall needs to be reported to the Competent Authority?

What Reporting path should I set up to effectively cover Recall, Incident Reporting, Post Market Feedback, Significant Change Notifications etc?

Back to Top

Class IIb & II Devices

HOME PAGE

Back to Top

Being Revised.....

HOME PAGE

Back to Top

For further information on any of the above issues or to post a further Question, please use this LINK  MDQA Feedback

Return to Medical Device & QA Consultancy's HOME PAGE

Copyright © 2001  Medical Device & QA Consultancy. All  rights reserved.
Revised: August 04, 2002 .