RQM+ is excited to announce the addition of Dr. Heike Moehlig-Zuttermeister as IVD Vice President Intelligence and Innovation. Heike joins us after nearly eight years at BSI, where she held leadership roles within the IVD team.
Heike has a PhD in molecular biology and immunology from University Hospital Kiel and undertook postdoctoral research in histocompatibility and molecular immunology at University Hospital Kiel and the University of Miami. She has over 15 years’ postdoctoral IVD industry experience including R&D and regulatory oversight across a range of diagnostic areas, from infectious diseases, autoimmune diseases to cancer and stem cell technologies.
Most recently, Heike joins RQM+ after almost eight years at BSI, where she held leadership roles within the IVD team. Heike was a significant contributor to BSI’s successful IVDR designation and helped shape the interpretation of the IVDR within Europe through her participation in expert panels by providing input into MDCG guidance and draft IVD Common Specifications, and participating in Notified Body working groups.
In her roles as Technical Team Manager and IVD Training Lead, she helped grow, develop and train BSI’s team of IVD technical experts in readiness for the enormous changes associated with the transition from the IVDD to IVDR. She led the implementation of key processes including the review of high-risk class D devices and companion diagnostics.
Heike was a final decision maker at BSI leading into final recommendations for IVDR and IVDD CE-marking and had the technical oversight for the first IVDR certificates issued at BSI. Heike was also the liaison between BSI and the Paul Ehrlich Institute in Germany, an accredited IVD testing laboratory in accordance with EN ISO 17025 and the IVDD (98/97/EC) and a central player in the EU conformity assessment.
Prior to BSI, Heike was Head of R&D for both AVISO GmbH and Institut Virion/Serion GmbH. Her role at AVISO included management and coordination of international research projects in regenerative biology and medicine within the EuroStemCell network and in the EU’s 7th Framework Programme “human embryonic stem cell research”, and development and validation of customized human cellular models (iPS-induced pluripotent stem cells) for disease research and drug development. At Institut Virion/Serion GmbH she was responsible for a broad device portfolio in the field of infectious diseases, autoimmune diseases and cancer.
A Passion for New Technology
With a background in research and development in the life sciences and diagnostics, and extensive regulatory experience, Heike is passionate about the impact of new technologies, putting safe and effective IVDs to serve individual patient management. Having worked on rare autoimmune diseases in her PhD thesis, Heike is dedicated to providing support in maintaining these “niche devices” (and others) on the market because she knows the personal value of these diagnostics.
Heike remains passionate in transferring her technical and regulatory knowledge to all stakeholders involved including manufacturers and regulatory bodies. At BSI she delivered multiple internal trainings, external IVDD and IVDR training, workshops and webinars, and presentations at conferences, providing tailored regulatory and technical education for attendees.
Having worked with multiple high-risk devices (such as Hepatitis, HIV, Syphilis tests) used in screening for transfusions and transplantations or HLA markers to be used in tissue typing, she understands the importance of the clinical benefit as these diagnostics can mean the difference between life and death for a patient.
Heike is fully committed to improving the quality and evolution of new technologies of diagnostics, bringing safe and reliable products to market and maintaining “niche devices” on the market.
An Asset to RQM+
Heike is working with the RQM+ Intelligence and Innovation team, providing thought leadership and helping to drive technical quality for in vitro diagnostics. Coming from both a technical regulatory and training leadership role at BSI exclusively dedicated to IVDs, Heike will be invaluable in her new role to influence best practices in the IVD sector.
Not only did she implement Notified Body processes for both the IVD Directive and Regulation, but she also created technical training content, position statements that are used by BSI reviewers in the assessment of IVD CE files and worked as a final decision maker leading into issuing IVDD/IVDR certificates which makes her a pivotal asset for RQM+.
At BSI, Heike reviewed a wide range of IVD products in all classes, spanning from complex, cutting-edge technologies such as molecular and next generation sequencing to immunoassays, flow cytometry, and immunohistochemistry. She is a true all-rounder when it comes to diagnostics, someone who can easily navigate regulatory requirements. She will be leading at the forefront of innovation across several functions of the business, including marketing, business development, training and consultancy services.
Why RQM+ is the Right Fit
For Heike, RQM+ means working with a growing company at the leading edge of innovation for medical devices and IVDs. She is excited to be in a position where she can influence change and drive-up quality for in vitro diagnostics through the large customer base of RQM+.
She is proud to have joined an organization where she can continue her endeavours to improve the standard of IVDs, whilst working flexibly and with an incredibly talented workforce, one that has quality and safety at the core of everything they do.
Top Challenges in IVDR Transition
The IVDR brings in substantial changes in place of the IVDD that had directed the regulatory landscape up until now. The level of scrutiny for IVDs has markedly increased with far greater Notified Body oversight and many new regulatory hurdles to overcome, in the form of EU consultations and expert panel reviews for the highest risk products.
The lack of robust infrastructure to support the transition is a major concern. EUDAMED and EU Reference labs preparedness, little MDCG guidance particularly around clinical evidence and, more importantly, Notified Body capacity are some of the key challenges that the industry faces.
With a ten-fold increase in the number of devices needing certification under the IVDR, there is a real risk of significant disruption to the supply chain, severely impacting clinical decisions for millions of EU patients who rely on diagnostics.
Also, we now have certainty on the proposed transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices which have been adopted without any amendments by the Council of the European Union on the 20th December 2021. This means there is no time to rest. The date of application of the IVDR remains 26th May 2022 with a progressive roll out of dedicated transition times considering the risk classification of IVDs. However, non-sterile Class A device have to be IVDR compliant to 26th May 2022 not having any transitional provisions.
With the limited Notified Body resources and limited infrastructure plus a ten-fold increase in the number of devices needing CE-marking under the IVDR, there is a real risk of significant disruption to the supply chain, severely impacting clinical decisions for millions of EU patients who rely on diagnostics
Having only six Notified Bodies designated to date, and a significant percentage of manufacturers not having a contractual agreement with a Notified Body in place for conducting IVDR conformity assessment work, it is of strategic importance for manufacturers to not delay their transition efforts and get prepared as much as possible. Thorough strategic planning for the entire device portfolio is everything right now!
How RQM+ Can Help
Heike brings even more IVD experience and expertise to the RQM+ team. Our client-validated IVDR transition processes, procedures and tools can help you efficiently achieve compliance and add value to your business at the same time. We know that the IVDR process can be overwhelming and planning now is a critical factor. With our proactive approach, RQM+ helps IVD manufacturers stay ahead with transformative solutions that integrate systems and add efficiencies to improve your business as a whole.
Learn more about our IVD services and how RQM+ can help your team.