What is the Minimum Documentation Required for Medical Device Industry?

[madhunaresh]

what minimum documentation is required by medical devices company apart from Major six documents.

[Ajit Basrur]

In Reply to Parent Post by madhunaresh

what minimum documentation is required by medical devices company apart from Major six documents.

Those 6 procedures are for ISO 9001.

For ISO 13485, refer this thread, ISO 13485 - List of required / needed procedures and records attached , where ISO MAN has prepared a list of procedures and records required for ISO 13485.

Btw, you could also do SEARCH in this cove to find out more on the ISO 13485 documentation. We have lot of valuable information.

[Beremiz]

Hi,
I'm a new member of the forum and I hope to learn something interesting for my job and to give a help using my knowledge in QA field.
I live and I work in Italy so I can give advises about European standards.
A company which wants to produce medical devices and wants to sell them in EU must follow some standards as:
1. European directive or guideline (i.e. Medical Device Directive 93/42/CEE, MEDDEV) surely
2. ISO 13485:2003
3. GMP

The documents required are listed inside these standards but their application can be decided by the Company on the base of its policy.

Bye

[Roland Cooke]

Be a little careful with the language here.

The MDD is not a standard. It is a regulation. (Or rather, the transposition of the Directive into Italian law is the regulation).


The MDD (typically) requires that a company implements a quality system. The standard that is accepted as meeting the requirements for that is ISO13485:2003.
But don't buy that. Buy ISO/TR 14969 instead. It is the official guidance for ISO13485, and includes all the standard elements within itself.


GMP simply means "Good Manufacturing Practise". However in some countries, the law requires you to meet that country's interpretation of what it considers GMP to be. In the USA, the law is essentially the QSR/GMP.


Finally, for other standards, you may wish to look at this list; click the relevant link.