Lead Auditor and Certifier Antal Solyom has worked for one of the most recognized Notified Body’s in Europe (TUV Rheinland) for 14+ years, and previously an additional 3 years at another Notified Body as a Lead auditor, and Head of Mechanical Laboratory. As a MS in Mechanical Engineering, his background provided the perfect base for gaining experience in a variety of non-active medical devices, adding over the years sterilization, clean room technology, biocompatibility and clinical data review knowledge. Leading the local certification office, and managing the worldwide-active auditors team, he earned a high level of experience in managing certification projects for a variety of medical devices for small and mid-size medical device manufacturers. Currently working for the leading CRO in Central Europe (HungaroTrial) these experiences are well used for projects coming from all over the world.
BRW:What do you hope attendees will gain at your event?
The Medtech sector faces the biggest challenge in the last 25 years. 2020 will be an incredibly tough year for all of us including the authorities and notified bodies. The new MDR brings a lot of interesting new aspects for all those associated with the industry. Understanding all the connections between the different parts of the regulation is not easy, not even for professionals. It takes a lot of time, effort and a need to immerse yourself as much as possible between the articles, chapters, and intense net of links between requirements.
Together with my colleague we put our combined 20+ years of experience in order to digest, filter and provide you the most important and challenging points of the changes, and to provide a clear supporting presentation of this information.
Because of the limited time, we can not present everything, but this is not our aim. Instead we will focus on important points which will capture your attention, and make it easy to prepare and plan for all important tasks for the next 2 years.
As a lead auditor for 14 years at a leading Notified Body, and being a certifier for 10 years, I realized the most significant problems and mistakes that manufacturers face. But nowadays there is no normal time: we are in the middle of the biggest change in medical regulation. This will trigger millions of questions, most of which cannot be answered yet, however attending conferences and round table meetings with regulators and authorities over the last year we have collated additional knowledge to support these questions.
BRW:What discussions do you look forward to having with attendees?
Understanding the relations and links between the chapters of the regulation is not easy, and triggers a lot of questions which are hidden in the deeper interpretation of the MDR. Based on the conferences attended in the past, together with the experience gained we have a good understanding of the most concerning points for the manufacturers, and we are prepared for these questions. Transition period and how to prepare and plan in the most effective way for it is a real deal for the manufacturers. How to gain advantage in some way is also a possibility for others. There is also a heavy side for other companies, who were not needed to work together with notified body’s until now because of the low risk level of their products – they have no transition period – they need to comply with the MDR right from May 2020.
All these cases will trigger questions which we are already prepared to answer, and will have the right response for the right manufacturer.
BRW:What do you enjoy most about your role?
As an engineer the possibility to take a peek into the manufacturing of the most developed and state of the art products of the “big” players in the last 17 years was far beyond all expectations when I started to work. The Medtech sector has provided me experience from real life situations, all together with real-life problems, and discovering solutions. This is I think the reason why I like my profession, and each day provides a new possibility to give something back to this industry with the regulatory support that we provide at the company.
BRW:How did you get into the industry?
Right after the university I was eager to start life as fast as possible – so I started at a company in the Quality Management field. After 3 years the possibilities were too finite – so I felt that I need to expand my horizons. Falling into the medical sector was a coincidence – but ever since that everything else was intended and planned. 3 years at the National Notified Body was a great opportunity to learn – and I used every minute of it for gaining knowledge from one of the best and experienced colleagues with many years behind their shoulders. After the possibilities became limited within the company, I felt it was time for something new. One of the leading Notified Body in the world was seeking auditors and experts in this area. Applying for that position began a 14 year long journey in this area with many challenges and possibilities. Travelling all over the world, auditing many companies around the world provided me unique experience in the regulatory field along side developing a strong relationship with competent authorities over the last 10 years.
BRW: Where is your favourite place in the world and why?
If it is outside, and close to nature I like every corner of the world, and I had the opportunity to experience many countries and continents. Be it the wild forests in Brazil, the National Parks in US, experiencing the cherry blossom in Japan or breathtaking mountains in Swiss Alps – the joy is the same – being close to nature is awesome. Being a skier from a family with multiple national champion skier parents provided me the possibilities to enjoy the nature even at the most highest altitudes throughout Europe.
Antal will be presenting HungaroTrial’s webinar: “The most challenging points of the transition period from MDD to MDR – and their solution” on the 5th December at 4PM London/11AM New York/8AM San Francisco. To learn more and register please click here.