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.

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