The RAPS Board of Directors is the governing, policy-making and strategic body that guides RAPS in serving the regulatory professional and the regulatory profession around the world. The Board of Directors has the legal and fiduciary responsibility to ensure the long-term viability and integrity of RAPS. The Board of Directors plays an integral role in maintaining a system of checks and balances that enables the organization to make strategic business decisions. Executive Director & Partner at Qserve Group, Dr. Gert Bos, has been appointed President Elect of the RAPS. Below, Gert shares his thoughts about this significant step.
What is the role of President Elect of RAPS?
Indeed, this is a great honor to be able to support the continuous growth and innovation processes at RAPS, a great organization from which members in our profession benefit. Many still remember their first ever RAPS conference, and typically, such experiences have been great and memorable. RAPS is about making friends, who understand one’s position inside their organization, and who focus on the same challenges.
On the RAPS board, my voice brings some of the device related ‘inside industry’ experience from Europe. Being involved in many projects within Qserve as CTO, as well as being involved in the informal interpretation and implementation stream of the EU-MDR and EU-IVDR, is most helpful in supporting RAPS on what is needed in this field.
This specific role as a member of the executive committee is part of a three-year commitment. This first year is geared towards being elected to the position of president of RAPS, with the remaining years towards chairman of the board. In addition, supporting the US conference, the EU conference and workshop planning, and supporting the Editorial Committee, will assist in preparing me for these upcoming roles. It is great to be part of such an enthusiastic team!
What are your goals?
I’m a big fan of clarity, transparency and sharing of information. And as such, I’ve had the privilege of sharing much information and thoughts on the MedTech regulatory affairs over the past decades, in conferences, workshops, training, blogs and whitepapers, to name a few. I hope to continue to do so, but also am very happy to see that this information sharing is done by an ever-growing crowd of RA professionals, using RegEx and social media such as LinkedIn and Twitter.
What I hope to contribute is the notion that it is possible to make the device world more transparent, more compliance driven, whilst still protecting businesses and stimulating innovation. That is the power of doing well for patients around the globe!
What are your regulatory preferences?
As all things in life, we pick and choose between the many options available to us. As much as I enjoy the global regulatory field, I am most passionate about regulations in the EU and China, for different reasons.
The changes in EU-MDR and EU-IVDR are significant, but what interests me most is the change of mindset. The new legislation continues to reflect on claims towards safety and performance, and that stimulated manufacturers, designers, and users to continue to think about the products and how to improve them and provide for an ever-safer healthcare solution for those in need.
For China, the staging is shifting. Where in the past China learned much from regions that started earlier with detailed legislation on medical devices, the last few years have shown that China is not shy to adopt a leadership role. Many things are changing, and as in Europe, all products need to have substantially more safety and performance evidence during the next renewal. Also, the overseas inspection regime is rapidly picking up steam.
Where do you get your inspiration? What inspires you?
I’ll start with your second question, as that is so much easier to address… I’ve learned early in life that it all comes down to your own initiatives. If you do not wait for others to guide you, but are innovative in your ways, take a leadership role in everything you do, inspire and motivate others, you will reap the benefits of your work. What is your action? What is your view? What inspires me is to see the bigger picture. Where do we come from, where are we, where do we go, and how do we make the most of it today? In the EU device world, we come from the legacy MDD, where all was feasible, and now we find ourselves in a setting to be more specific in requirements, with EU-MD looking at continued compliance, but still in a semi-decentralized way. Perhaps in a decade or two, we may see a new regimen coming towards us, with a centralized agency handling most critical products. Those that see changes coming and are willing and able to adapt ultimately will be leading the future.
My inspiration comes from various sources, some of them quite personal, that brought me to hospitals too frequently, as family members found themselves in need of the critical healthcare systems. But those events and moments made me realize how important it is that the system is ready to support patients, in their moment of need. I also credit my education, since I was raised with the notion to do your best, while serving the people in the community and world around you.
What is your dream?
What excites me is to see people inside the various companies, as well as within our own global Qserve organization, slowly adjusting to the new expectations in regulatory affairs. I envision the early adopters and slow starters and see the bigger picture versus the details that follow. I see a landscape of companies and people rapidly changing as if they were seeing the early morning sun change the colors of the surroundings, lifting the fog, making the birds sing. A happy morning predicting a beautiful sunny day where everyone will enjoy the buzz of the day makes me smile. Working effectively, and, in line with the perfect work-life balance, relaxing and enjoying an evening sunset with a nice glass of wine is a terrific way to end each day... knowing you’ve contributed again, even a little bit, to make someone’s life a better one.
Gert is an expert in the regulatory industry, specifically the EU-MDR regulations, with 21 years’ experience in the field as an auditor, product reviewer, regulatory specialist, and head of notified body. He has been leading the Notified Bodies in Brussels for many years and has been an advocate of the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both the operational and strategic level. From his PhD in Biomaterial Sciences, to his post-doctoral work in controlled release of drugs and gene therapy, he has acted as a technical reviewer with a large range of devices, mostly in the non-active sector. He has been awarded a RAPS Fellow, for his contributions to the regulatory profession over the last decade.
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