posted on 26-Mar-2020 by Ann Vankrunkelsven
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on timelines, EUDAMED implementation and Notified Bodies. This update is focused on the proposal to delay the date of application of the MDR by one year.
posted on 17-Mar-2020 by Ann Vankrunkelsven
When creating a QMS from scratch, you need to decide which processes or procedures to write first and how to approach this. In the second post of this series we focus more on how to write processes and where to start.
posted on 09-Mar-2020 by Ann Vankrunkelsven
Bringing a medical device to the market implies setting up a Quality Management System. When starting from scratch, the first things to take into account are the regulatory requirements, the role of your organization, the scope of your QMS and the structure of your QMS. This is the first post in a series on how to get started building a QMS.
posted on 20-Feb-2020 by Ann Vankrunkelsven
Depending on your market, different versions of the same standard might be applicable to your product or organization. For example, EN ISO 14971:2012 is the harmonized standard in Europe while ISO 14971:2019 is the consensus standard in the US. Which one should you choose?
posted on 07-Feb-2020 by Ann Vankrunkelsven
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on timelines, EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up. This update is focused on the state-of-play documentation regarding the NBs accreditation for the MDR and IVDR.
posted on 03-Feb-2020 by Ann Vankrunkelsven
Currently the trade of medical devices between the EU and Switzerland is regulated through a Mutual Recognition Agreement (MRA). However, this MRA has not been updated to be valid in combination with the Medical Device Regulation (MDR). What is the impact on Swiss manufacturers?
posted on 20-Dec-2019 by Ann Vankrunkelsven
This post describes the 3 main changes in the new version of ISO 14971. It focuses on new/adapted definition, risk acceptability and ISO/TR 24971
posted on 05-Dec-2019 by Ann Vankrunkelsven
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on timelines, EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up...
posted on 21-Nov-2019 by Ann Vankrunkelsven
Software is taking a more prominent role in medical device legislation all over the world. Matrix Requirements recently presented on this topic at the Biolago Academy event.
posted on 12-Nov-2019 by Ann Vankrunkelsven
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up...
posted on 09-Oct-2019 by Ann Vankrunkelsven
This blog gives an overview of the information currently available about the MDR transition status. It's mainly focussing on EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up...
posted on 04-Oct-2019 by Ann Vankrunkelsven
This post is a summary of FDA's new guidance on Device Software Functions and Mobile Medical Applications, published on September 27th 2019.
posted on 27-Sep-2019 by Ann Vankrunkelsven
Both the US market as well as the EU market are highly regulated for medical devices. However, there are some specific things to take into account when crossing the Atlantic.
posted on 22-Aug-2019 by Ann Vankrunkelsven
Software validation is required by different standards and legislation related to medical devices such as 21CFR Part 820 as well as ISO 13485. This also applies to software used in a QMS. Here we explain what is the most important when validating software used as part of the Quality Management System.
posted on 29-May-2019 by Ann Vankrunkelsven
Traceability is important from the very start of the design, during production and throughout the entire supply chain. Traceability is not a static linear connection between your requirements and test forms, it's a global concept, a matrix connecting the complete life-cycle of a product.
posted on 06-May-2019 by Arnaud Alberts
How to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing? In the recorded webinar, you will see the added value and the most efficient testing workflows using a modern SW tool like MatrixALM. Watch the recorded webinar here!
posted on 02-May-2019 by Wolfgang Huber
For hundreds of years there is a seemingly simple puzzle around - it's called Tangram. Well it's not that easy.
posted on 23-Apr-2019 by Ann Vankrunkelsven
The Medical Device Regulations (MDR) are coming closer and for some companies, they'll have a significant impact. Here we discuss the impact on stand-alone software classification.
posted on 03-Apr-2019 by Arnaud Alberts
How to keep the risk management process efficient with a fast moving product development? We show some practical examples in the following webinar. Watch the recorded webinar here!
posted on 02-Apr-2019 by Ann Vankrunkelsven
Design reviews are an essential step in your design and development process. How can you manage them if you are using an Agile process where everything can and does change all the time?
posted on 22-Mar-2019 by Ann Vankrunkelsven
In this blog post we want to share our experience with integrating an Information Security Management System based on ISO 27001 into our existing Quality Management System based on ISO 13485.
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.
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!
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…
posted on 03-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…
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.