Medical Device Files - ISO 13485 section 4.2.1 requirements

[Bandauk]

Hope I have posted this in the right place.

My company is an independant Medical device servicing company, ie we service Medical devices for the NHS, GPs and other smaller manufacturers in the UK, and we are currently setting ourselves up to go for ISO 13485. We already have ISO 9001, so not too much of a leap to get 13485 (or so I hoped!)

The problem I have is in section 4.2.1 which states that "for each type or model of medical device, the organisation shall establish and maintain a file either containing or identifying documents defining product specifications and QMS requirements." We service many types of devices from many manufacturers, and if we have to create a file for each one would take me a very long time!

What information needs to go in the file, and how can I minimise the amount of work to be done?

All help will be much appreciated.

Many Thanks

Andrew

 

[SteveK]

Hi Andrew,

Welcome!

Since you do not manufacturer Medical Devices you will not need a Technical File as defined by the MDD as such (4.2.1) – you do not control the product specifications, Essential Requirements, Risk Management etc. You might well have copies of product manuals, datasheets, specifications, operating instructions, service schedules etc from the manufacturers which can show you are maintaining an overall file. It is 7.5.1.2.3 ‘Servicing activities’ as part of the overall QMS that I feel is important. Consider (if not already the case) having SOPs for e.g. Customer Site Risk Assessments, Maintenance and Servicing at a customer site, Installation etc – i.e. generic procedures.

Steve