The 26th of May 2024 is soon here!

Ensure that your Quality Management System (QMS) is up to date and in line with the EU/EEA Medical Device Regulation (MDR) before 26th of May 2024.

Many medical device manufacturers, obliged to have a Notify Body acceptance and supervision, are still in the process of transfer from MDD to MDR and intend to use the advantages of further extension of MDD certification from its current Notified Body.  To be able to use this advantage, application to your Notified Body for MDR assessment needs to be in place before the 26th of May 2024 and the achievement of an agreement no later than 26th of September 2024.

In addition, do not forget your Quality Management System (QMS) which is required to be in line with requirements stated in MDR no later than May 2024. A QMS certified according to EN ISO 13485:2016 also most likely needs additions and adjustments to fulfill MDR.

To establish, implement, maintain, and improve the QMS to ensure compliance with both the ISO 13485:2016 and MDR in an effective way, is not always obvious. There are often a lot of considerations to ensure that the QMS fulfills the purpose for the organization and applicable requirements.

If you need a second opinion or a GAP analysis of your current QMS in relation to the MDR requirement, contact us at for more information.


Our team is growing.

We start 2024 with a warm welcome to our new team-members, Ekaterina Riabova and Lee Ambolt to our office in Lund.

QAdvis is happy to welcome Ekaterina and Lee to our growing team of experienced quality and regulatory consultants. This strategic expansion is a testament to our commitment to continuous growth and to be able to meet the current and future quality and regulatory requirements in a sector that is ever-evolving.

Their collective background within the medical device sector, especially with clinical evaluation and SW, ensures that our consulting services remain at the forefront of innovation and compliance.

If you want to learn more about Ekaterina and Lee and their experiences and how QAdvis can contribute to your business, contact us at or call us at + 46 86 21 01 05.

The 8th EAAR Annual Conference on the New Medical Device Regulations

The EAAR Annual Conference on the New Medical Device Regulations (RMD2024) will this year take place in Brussels on 26-27 February 2024.

It is the 8th consecutive year with seasoned speakers from the medical device industry, including EU Commission, competent authority and notified bodies.

It is a fantastic prestigious 2-day event, this year held at Sheraton inviting attendees to listen, learn and discuss the latest development of European regulations. QAdvis founder Nils-Åke Lindberg, member of MDCG Standards will this year speak on the topic of the latest state-of-play on the EU harmonisation process of ISO/IEC standards.

You are also very welcome to sign up for one-to-one meetings with Nils-Åke or other speakers, or just connect and discuss during breaks between the sessions.

Read more about the speakers here.

RMD2023 homepage

Registration here

If you have any question, contact us at

AI systems: The Benefit / Risk balance

Autonomous cars and medical devices are only two examples of autonomous systems, which are systems that can achieve a specified goal, independent of detailed programming. These systems have both risks and advantages that need to be considered by manufacturers, users and regulators alike.

Autonomous systems can increase efficiency and productivity by reducing costs, saving time and optimizing resources. They can also improve safety and security by preventing or mitigating human errors, hazards or threats. For example, self-driving cars can avoid collisions, obey traffic rules and react faster than human drivers. A study published in Plos One on autonomous vehicles shows that if this is properly regulated the benefits outweigh the risks.

Likewise, AI in medical devices can monitor vital signs, suggest diagnosis, administer drugs and perform surgeries with more precision and accuracy than human clinicians. However, they also pose significant risks and challenges. They may fail to deliver the intended therapy or harm the patients due to general IT-risks like software bugs, cyberattacks and technical errors. Therefore, autonomous systems need to be designed, tested, and monitored with high standards of safety, reliability and security. These types of risks are however already well known from other software systems and there are strict regulatory requirements to handle these issues.

AI-based software can introduce new types of errors, biases, or harms that may affect patient safety. As an example, one challenge is to balance the benefits and risks of an AI-enabled medical device. Their complexity makes it difficult to explain or understand how they work or why they make certain decisions. And since the training data generally is not known to the healthcare professionals it can be difficult to determine the device efficiency in different patient groups. Is it equally effective regardless of sex, race or other parameters that were not represented in the training data?

A study by The Lancet Digital Health, shows that the approval of AI-based medical devices in the USA and Europe has increased significantly in recent years, but there are still gaps and inconsistencies in the regulatory frameworks and evidence standards. The study suggests that more harmonization and transparency is needed to ensure the safety and effectiveness of AI-based medical devices.

Therefore, it is important to have a clear and consistent framework for assessing and regulating AI-enabled medical devices that considers not only their technical aspects but also their ethical implications so we can ensure that they are trustworthy, beneficial, and respectful of human values.

In the next episode of this article series we will therefore look at the upcoming AI regulations.

If you have any question, contact us at