Jan van Lochem, CEO:
With 2022 almost behind us, we prepare for a well-deserved Christmas break, look back at our achievements, and at the same time plan for new initiatives and objectives in 2023.
For Qserve, 2022 has been a strong year of growth welcoming a lot of new clients, initiatives, and colleagues joining our global team. At the start of the year, we moved to a new structure of four global business units to create more focus and specialization: Medical Device Consultancy, IVD Consultancy, CRO & Clinical Writing, and Global Registrations. Technological innovation and the regulations worldwide cause increasing complexity and specialization, which forces all stakeholders in the medical device space to strengthen their expertise and resources, needed to successfully bring devices to and maintain them on global markets. To support the increasing demands of our customers, we have further expanded our expertise, capacity, and scope of service offerings. Qserve has become a global CRO and Consultancy, with a full scope of services in the quality, regulatory and clinical areas to help customers with market access to global markets.
After the launch last year of our UK representation service following BREXIT, we are now the second provider of UK Responsible Person services for the UK market, helping more and more customers with registrations in the MHRA database to allow continued UK market access.
More manufacturers have found our CRO for clinical studies, leading to our CRO doubling in size this year. Our customers see the benefit of having a CRO for their European clinical trials who also has strong regulatory expertise and experience with Notified Bodies and the implementation of the EU MDR. This ensures a practical approach and successful outcomes to support CE certification.
In addition to pre- and post-market clinical trials, we have successfully delivered an increasing number of PMCF surveys this year. This is a ‘light’ alternative for a PMCF study to gather evidence for especially legacy devices already in the market who are required to have clinical data for MDR certification. Using this as input together with literature searches to create Clinical Evaluation Plans and Reports, we have been able to deliver CEP/CER’s for our customers with a 100% score to achieve CE certification. I am proud of our clinical writing team for this result.
Another area of growth has been our services related to helping customers with US market access. As the MDR and IVDR lead to a lot more effort to achieve or maintain European market access, we have seen a growing number of projects to help customers with 510(k) or PMA’s. As part of this trend, we see a steep growth in the number of manufacturers for which we act as US agent.
Our IVD team is best of class and supports an increasing number of customers in the US and Europe with EU IVDR implementation as well as 510(k)’s for US market access.
Across medical devices and in-vitro diagnostics, we have seen increases in the number of audits, either of suppliers, or mock audits in preparation for MDR assessments, or Due Diligence assessments for investors. This shows the increasing importance of compliance for manufacturers and the impact of regulations on business.
With this in mind, we are looking ahead to 2023, starting with the recent news of the publication of a draft amendment to the MD regulation by the European Commission to extend the validity of existing certificates for devices placed on the market before May 2021. This does not come as a surprise and will help all stakeholders with an orderly implementation of the EU MDR. When adopted, this will help to maintain existing devices on the market till 2027 or 2028. While this measure is needed to prevent a healthcare crisis in Europe, it is still very important for manufacturers to continue efforts with the same priority to achieve MDR or IVDR certification. Bringing technical documentation at MDR/IVDR level and certainly gathering own clinical data is time-consuming, aside from getting an assessment slot with Notified Bodies. Besides that, MDR/IVDR certification is needed to bring new devices to market.
Hence 2023 will be a year full of regulatory change and challenges again and Qserve is ready to support our clients to navigate successfully through this.
We thank you for the opportunity you have given us this year to help you with your clinical trials, regulatory projects, compliance, audit, or clinical challenges to bring devices to global markets.
On behalf of the whole Qserve team, I wish you a Merry Christmas and a healthy and successful 2023!
We look forward to serving you again to help you achieve your objectives in the new year.
Warm regards,
Jan van Lochem
CEO Qserve Group