RQM+ is excited to announce the addition of Dr. Andrew Tarnaris as Medical Director. With a background as both a medical doctor and notified body clinical expert, he represents an excellent example of our unique combination of clinical and regulatory experience.
Clinical Professional Background
Dr. Tarnaris is an experienced medical doctor with 20 years of postgraduate experience and a history of working in hospitals and other healthcare environments. He is a fully qualified neurosurgeon with subspecialty expertise and interest in functional neurosurgery and neuromodulation and expertise in active implantable devices for chronic pain management.
Additionally, he has extensive experience with clinical trials, medical devices, mentoring and training healthcare staff, and healthcare management. Dr. Tarnaris has a widely recognized academic background with a postgraduate research degree awarded from University College London (MD Res) focused in clinical/medical laboratory science/research and with 35 publications in peer-reviewed journals, more than 1,200 citations, and an h-index of 20 as of 2021.
Regulatory Professional Background
In addition to his clinical background and surgical expertise, Dr. Tarnaris has regulatory experience in the medical devices industry as a former clinical expert at BSI on their Active Implantable Devices team. He assessed the first successful Class 3 active implantable medical device application under the new EU MDR.
During his time at BSI, he gained in-depth understanding of the European medical device regulations, and, in particular, the requirements for clinical evidence, post-market surveillance and vigilance, and post-market clinical follow-up. Throughout his career, he has built an extensive network of clinicians from different clinical fields through his participation in various academic groups, committees, and learned societies, including BNS, BSSFN, BNTA, and International Society for Hydrocephalus and CSF disorders.
A Passion for Patient Care
The common thread in Dr. Tarnaris’ career trajectory is a passion for patient care and improving lives. As a medical doctor, he could have an impact on the health of individual patients. However, as a clinician, it always concerned him that he didn’t have a deep understanding of the regulatory process for the medical devices he recommended. Clinicians rely on regulators to ensure that there is sufficient data to support the intended use and identify the gaps. He wanted to explore that process further by gaining firsthand experience as a regulator.
His transition to the regulatory world opened his eyes to what goes on in the background and the rigor required to get a medical device to market. His role at BSI illuminated the need for more clinician involvement within the regulatory process. Engineers are highly skilled at technical assessment, but clinical evaluation after a product has gone to market is also a key part of the process.
The transition to RQM+ offers Dr. Tarnaris the opportunity to have an even greater impact on patient outcomes by helping manufacturers understand the patient’s journey and how to meet regulatory requirements to ensure their products can be placed on the European market with the right indications in place to improve patients’ lives.
An Asset to RQM+
As a medical doctor, Dr. Tarnaris’s knowledge of the clinical sector and patient needs will inform RQM+ business intelligence and sales strategy, particularly in addressing the challenge of getting manufacturers to transition to thinking about MDR. His clinical experience also enables him to support writers in creating good clinical documentation, provide valuable input to guide regulatory and post-market clinical strategy, and teach internally to grow the RQM+ unrivaled collective knowledge.
As a neurosurgeon, Dr. Tarnaris has a deep understanding of risk management from a clinical perspective and a pragmatic understanding of what happens in the field with patients. Neurosurgery is a relatively new specialty in the medical world, so neurosurgeons are accustomed to dealing with a lot of unknowns and must stratify risk, find evidence, and make the best decision for each patient. For MDR submissions with limited or no clinical data, manufacturers must make the most of the data they do have without compromising patient health. As a clinician, he is able to think creatively about how to present the data that exists while understanding the risks and keeping patient needs at the forefront of this process.
His regulatory experience gives him an excellent understanding of MDR regulations and the process for bringing products to market. His experience assessing technical documentation under both AIMDD and MDR has given him insights into the regulations and how both manufacturers and reviewers are interpreting them. As a reviewer, Dr. Tarnaris felt frustrated with the inability to provide consultation to manufacturers because reviewers are not allowed to coach. This is one reason his role at RQM+ is so appealing.
Why RQM+ is the Right Fit
Dr. Tarnaris is excited about many aspects of his new role at RQM+, particularly the ability to apply problem-solving skills within the boundaries of the regulations. This is what we at RQM+ do best. He also appreciates the freedom to advise manufacturers on how to meet the requirements—which he couldn’t do in his role at BSI—and help them submit the best possible application. As a natural problem solver, he is also looking forward to the potential to propose solutions when gaps or risks arise, supporting his passion for patient care.
Top Challenges in MDR Transition
RQM+ is constantly improving as we expand the skills and experience of our team. Dr. Tarnaris expects to help us tackle some of the most common challenges manufacturers face with the transition to MDR, including manufacturer assumptions, legacy devices, and clinical strategy.
Dr. Tarnaris frequently hears manufacturers make assumptions about the ease of getting legacy devices approved under MDR. The most challenging of these assumptions is that just because a device was certified under MDD or AIMDD, it will be easily certified under MDR. Many do not understand that they must present a minimum level of clinical evidence—even if the device has been on the market a long time. RQM+ can help manufacturers develop a clinical evaluation roadmap, remediate files, and find relevant clinical data to support claims for legacy devices.
The most frequently made assumption by manufacturers is the incorrect assumption that having U.S. Food and Drug Administration clearance means that no further work needs to be done to meet EU MDR requirements. The reality is that FDA approval does not assume automatic EU approval. When manufacturers work with RQM+, they get the benefit of former notified bodies who know what the actual expectations are. The result is fewer questions from the notified body and a faster review.
Bundling devices under one CER is a smart strategy when executed well, but many manufacturers try to put too many devices together. With our clinical and regulatory expertise, RQM+ can provide an early strategy for the best way to bundle devices with the same intended purpose for a more efficient review.
How RQM+ Can Help
Dr. Tarnaris brings even more clinical and regulatory experience and expertise to the RQM+ team. Whether you are bringing a new device to market or getting approval for a legacy device, we can help you develop a clinical evaluation roadmap and post-market strategy that matches what reviewers expect to see. We know that the MDR process can be overwhelming and that time is often a critical factor. With our proactive approach, you can move through the review process more quickly with fewer questions, ultimately leading to faster approval.