Does quality and regulatory pose a challenge to Innovation?

Quality and Regulatory Affairs is often regarded as being a hindrance to innovation. We think this is a very counterproductive way of looking at it. We see the QMS more like the barrier between the opposite lanes of the motorway preventing you from a head on collision in case of an innocent mistake.

Sweden is a home to over 600 medical technology companies, employing five people or more, and collectively providing employment to over 50,000 individuals. A nation of just 10 million people, has been the birthplace of a remarkable number of inventions that have left an indelible mark on the world. It may seem that all it takes is a brilliant idea to make a significant impact, but the reality of medical device development is more complex. Regulatory compliance is a critical aspect of this process, that ensures user safety, maintains quality, and secures market approval. However, far from being a hindrance, regulatory compliance can enhance innovation efficiency and open up new opportunities for innovation. It’s all about finding the right balance between regulation and innovation. Thepurpose of regulatory affairs is to secure market access for a safe and effective product as quickly and painlessly as possible – not to hinder innovation. And that is exactly our cup of tea, Regulatory compliance with the least burdensome approach. The number of companies that we have helped and continue to help is our legacy of success. We are proud that we have the opportunity to support several top-rated medical device companies in Sweden.

The list of Swedish contributions to the world includes significant inventions such as the ball bearing, refrigerator, adjustable spanner, and the three-point seatbelt, just to mention a few.

The country has also made significant strides in the software realm, with globally recognized contributions like the game Minecraft, Bluetooth technology, Skype, and Spotify.

In the healthcare sector, Sweden’s contributions to the 20th century have been nothing short of transformative. The world’s first clinically usable artificial kidney was developed in 1946, followed by the Servo ventilator in 1950, medical ultrasound in 1953, the implantable pacemaker in 1958, and the Gamma knife in the late 60s.

More recent innovations include the Bone Anchored Hearing Aid (BAHA) in 1977, the Turbuhaler® Inhalator in 1987, and the Lucas Chest Compression System® that provides mechanical chest compressions to patients in cardiac arrest, introduced in Swedish ambulances in 2003. Medical devices have a huge impact on the lives of patients everywhere. It is therefore important that innovation, quality and regulatory affairs co-work and not counteract each other.

If you have any question, please contact us at


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