Quality assurance and regulatory compliance are not something you can buy out of the box
For medical device and IVD companies, bringing a product to market involves much more than meeting a list of regulatory requirements. It requires an understanding of why those requirements exist, how quality supports the organization and, ultimately, how it contributes to safe and effective products.
For Lars Mentzer, Senior Consultant at GBA Key2Compliance, this broader perspective is one of the most important lessons from working with companies in the medical device industry.
Lars has worked with QA and RA within life sciences since 1994, with experience spanning quality management systems, regulatory compliance, product development and product supply. Before joining GBA Key2Compliance, he worked with startup companies where his responsibilities included implementing quality management systems, managing CE registration and supporting the setup of internal and external production sites. This broad experience has shaped his pragmatic and holistic approach to QA and RA.
Understanding the “why” behind quality and regulation
One of the biggest challenges Lars sees today is not necessarily a specific regulation or requirement. It is understanding why strong quality assurance matters in the first place and why the medical device market needs to be regulated.
When quality and regulatory requirements are viewed primarily as obligations, it can be easy to focus on completing individual tasks rather than understanding how the different pieces fit together.
According to Lars, this can lead to a common misconception: that quality assurance and regulatory compliance can simply be bought as a ready-made solution.
“QA and regulatory compliance are not something you can buy out of the box.”
Companies may put a quality management system, procedures or external support in place and believe that the work is essentially complete. In reality, maintaining quality and compliance requires ongoing knowledge, understanding and commitment within the organization.
Quality is not something that can simply be implemented once and then left alone. It needs to remain part of how the company works.
Looking beyond QA and RA
Years of supporting clients have also taught Lars the importance of seeing the bigger picture.
For consultants working with medical device companies, expertise within Quality Assurance or Regulatory Affairs alone is not always enough. Lars believes that supporting companies effectively requires a holistic understanding of what it takes to bring a medical device to market.
QA and RA are connected to many other parts of the product journey, and understanding those connections makes it possible to provide advice that works not only on paper, but also in practice.
An area to watch: usability
Looking ahead, Lars believes usability is an area that will receive increasing attention.
For medical device companies, it is therefore an area worth keeping on the radar as quality and regulatory expectations continue to develop.
A career that “just happened”
When asked what originally drew him to a career in Quality Assurance and Regulatory Affairs, Lars gives a refreshingly straightforward answer:
“Nothing, it just happened.”
What has kept the work meaningful, however, is the opportunity to put his experience into practice.
For Lars, one of the most rewarding aspects of being a consultant is being able to use his experience to help others improve things in their everyday working lives.
It is the practical side of consulting that matters: turning knowledge and experience into improvements that make a difference for clients.
Good quality takes investment
If there is one reality companies should understand about working with quality and regulatory compliance, Lars puts it simply:
“It takes time and it costs money.”
Building the right knowledge, maintaining systems and processes and keeping compliance alive throughout the organization require resources and continued attention.
QA and regulatory compliance are not one-off activities that can simply be completed and forgotten. They need to be understood as part of the bigger picture of bringing a medical device to market.
Facing a QA or regulatory challenge?
At GBA Key2Compliance, our consultants combine regulatory expertise with practical industry experience to support medical device and IVD companies throughout the product lifecycle.Get in touch with us to discuss how we can support you with your QA or regulatory needs.