5 possible pitfalls when your procedures need to comply with different standards

posted on 15 Mar 2019 by Ann Vankrunkelsven
ISO 13485, ISO 9001, ISO 27001, ISO 14001 are all examples of standards in management systems. All of them are based on the same kind of principle, but they do have their own specific approaches and focuses.

This blog gives you 5 things to pay attention to when integrating different management systems.

Can medical device software be updated and released in an Agile way ?

posted on 17 Feb 2019 by Arnaud Alberts
What are the modern methods for Agile Design Controls for Medical Devices? We recently made a webinar explaining this and providing visual examples of Matrix Requirements application: MatrixALM.

Watch the recorded webinar here!

When is a good time to switch from a paper-based to an electronic QMS ?

posted on 15 Jun 2018 by Ann Vankrunkelsven
For companies that are implementing a QMS from scratch, my advice would be to start immediately with an electronic QMS (eQMS). It will save you so much time, effort, frustration and money in the future!
But what if you already have a paper-based QMS? And you are busy developing and improving your devices? And you have all these procedures in their nice binders (which nobody reads) and records in other binders. And the auditors seem to like it this way…

Does a QMS have to be static or can it be agile as well, is it worthwhile the effort going for it ?

posted on 3 Mar 2018 by Ann Vankrunkelsven
The QA department is like a zombie island. We all know about it, but we don’t want to go there. They seem to be living on dead paperwork. They have a thing called a QMS. It comes with rules and procedures, which never truly reflects the real way of working, but it’s just too much effort to change them…

ISO 13485:2016 - the new version has arrived!

posted on 24 Mar 2016 by Wolfgang Huber
Besides adding many details the main changes are that you need to do a risk assessment on all processes. The design and development requirements also have changed significantly, for example new requirements for the design transfer and design development files have been added. Another big change is that you have to validate software used to maintain your quality system.

IEC 62304 2015 - impact on Class A software

posted on 17 Mar 2016 by Wolfgang Huber
What changes for Class A software with the updates of 62304:2015.

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