Top Three Document Management Tips for Medical Device Companies

Avoid the headache (and citations) by establishing electronic document control

Wed, 07/08/2015 - 12:00

In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.

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We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing risk management, to name a few.

Documents and records serve as proof that your medical device company uses compliant document management practices when designing, developing, and manufacturing health industry products.

And like it or not, how you manage your documentation can make or break you.

That’s why it’s essential to take the time to consider how your company will manage all of its documents and records, not just now, but long into the future.

Here are three key tips to consider when building a system for managing your documentation that will work for your organization.

Tip No. 1: Develop a document management strategy

Develop a document management strategy and do it early. To get started:

Map out all the types of documents and records that will be generated throughout medical device product realization.

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Comments

Submitted by cgarofano on Fri, 01/22/2016 - 09:19

Hi John and Alex,

My company does not have its own product, we manufacture per the customer's drawings, BOMS and instruction.  We make cable, harnesses and wiring assemblies, battery packs and box build assemblies for companies that make actual medical devices.  We are working on a gap analysis from ISO 9001 to 13485 with the goal of becoming 13485 registered.  Do we have to have a separate procedure for customer complaints or can the requirement for feedback be part of our CAPA system documentation?

Regards,

Cgarofano

Response from Grant Ramaley via Quality Digest:

Yes, integrate the Complaint system with the CAPA system!  They are typically investigated the exact same way. I have done this, and in fact my CAPA form is also a Complaint Form (see attached).  I’m  sure they will love the sample.  And I just passed a BSI ISO 13485 audit, and they were most impressed at our joining the two processes into one.

Being a partner to a medical device company means addressing and communicating complaint/CAPA details, to keep their customers out of hot-water.  This is the added value of their ISO certification.  We have confidence they will help us determine the magnitude of the problem, based on detailed root cause analysis, perhaps only they can do.  

So yes, integrate Complaint system into CAPA!  Make sure the company you hire is accredited by an IAF member ; )

Bonus – Here is the ISO 13485:2016 definition for Complaint. Add this to the CAPA procedure to sweeten the auditors impression!

Complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices

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