CUSTOMER SUPPORT SERVICES

New Links Recently Added

Added October 2002

Annex X - Clinical Data Requirement - What data must I assemble, in order to meet Essential Requirement # 14?

Added September 2002

- Clinical Trials - The only standard currently 'Harmonized' is EN 540:1993. The International equivalent ISO 14155:1996 has been used by some manufacturers, as certain parts were clearer and less ambiguous than EN 540 and thereby afforded a better level of control.

Currently, ISO 14155 has been adopted as a European Standard as is progressing through it's DIS (Draft International Standard) phase.

The standard which is titled "Clinical Investigations of Medical Devices for Human Subjects" will consist of two parts: prEN 14551-1:200x - "General requirements" and prEN 14551-2:200x - "Clinical Investigation plans".

The ISO/DIS versions are available now and the published versions are expected 2nd quarter 2003.  

- What are Notified Bodies focusing on currently?

- For those of you who want copies of all European Directives, follow this Link

The Harmonized Standards that will demonstrate compliance are also listed

Added June 2002

Post Market Feedback / Surveillance will be more strictly audited by Notified Bodies, in the light of Reported Incidents, Safety Alerts and Product Recalls.

How can I ensure that I have an effective Post Market Feedback System?  

Added March 2002

Get the correct dimensions for your CE Mark

Added January 2002

What new aspects are Notified Bodies including in Audits currently?

Download a copy of Directive 1999/44/EC "aspects of the sale of consumer goods and associated  warranties".

Added December 2001

What Option's Do Medical Device Manufacturers Have for Compliance with the Regulations and Quality Systems?

Added October 2001

How do I implement a "Process Approach" for ISO 9001:2000?

Where can I get a list of what a Technical File should contain?

For Class I Devices, what proof of CE Certification is required?

Sample Post Market Feedback Procedure

Added September 2001

Summary of the Five sections of ISO 9001:2000

Deming's [P]plan [D] do [C] check [A] act cycle and ISO 9001:2000

Added August 2001

Examples of EN 980 Medical Device Symbols

Do you need Assistance to arrive at the correct Classification of your Products?

Are your CE Mark Dimensions correct? Annex XII is the answer.

Download a copy of the Medical Device Directive 93/42/EEC

Download a copy of the IVD Directive 98/79/EC

Download a copy of the AIMD Directive 90/385/EEC

Download a copy of the Packaging and Packaging Waste Directive 94/62/EC

When will the revised Medical Device Directive be published?

What issues will the review focus upon?

What issues are Notified Bodies focusing on currently, during Medical Device audits

Added July 2001

Are Class IIb Medical devices going to be re-classified as Class III?

A Medical Device version of ISO 9001:2000

More than 6 Documented Procedures needed for Medical Device Manufacturers ?

Top Management Vision & leadership, now being audited by Notified Bodies