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“MDSAP is a quantum leap for manufacturers”

Interview with Hendrik Heinze, Director Quality and Regulatory Affairs at Berlin Heart GmbH

Under the Medical Device Single Audit Program (MDSAP), medical device manufacturers need to undergo only one single audit to test their quality management systems and compliance with further regulatory requirements from Canada, Australia, Brazil, the USA and Japan. MDSAP underwent a pilot phase from 2015 to the end of 2016. German medical device manufacturer Berlin Heart was the first company to be audited by TÜV SÜD during this period – an enlightening experience for both sides. Hendrik Heinze, Director Quality and Regulatory Affairs at Berlin Heart, looks back.

Mr. Heinze, you joined the MDSAP as a voluntary participant in 2014. What convinced Berlin Heart to participate in the pilot phase of the program?

Our ventricular assist devices are high-risk products that must fulfill a wide variety of increasingly strict requirements throughout the world. Our audit scope increases every year. We would actually need a full team of regulatory affairs experts, but for  a medium-sized company like Berlin Heart, the costs arising from such a measure would be enormous. However, we have always been a highly innovative enterprise and are always ready to explore new avenues to improve the efficiency of our processes.

What makes MDSAP so appealing for small and medium-sized enterprises?

The program suits all manufacturers of medium- and high-risk medical devices that plan to operate on a global level. You have to remember that every market requires an audit with a duration of roughly one week. The new harmonized standard under the MDSAP covers the requirements of five markets in one single audit. This is highly efficient and reduces costs and efforts for our company, but also for the regulatory authorities in the participating countries. The MDSAP assessment criteria are standardized, clear, and transparent for all parties involved. As a manufacturer, we know exactly what we have to do, which allows us to precisely focus on our direction when implementing the many different regulations.

Were there any concerns in the beginning?

Of course, when exploring new avenues there are always concerns that something unexpected might be lurking behind the next corner. When we joined the program, the MDSAP was after all still at the very start of its pilot phase and thus designed as a learning process. It was challenging for both sides – for us as the manufacturer, but also for the TÜV SÜD experts for whom it was their first audit under the MDSAP. Our first audit was carried out as a witness audit, which means that representatives from the competent authorities – in our case, the FDA and Health Canada – attended the audit to assess TÜV SÜD’s audit process. For all of us, this was the first “go-live” in which we had to prove that we were able to apply the new regulations and draw the right conclusions from them. We all succeeded very well in identifying problems and solving them together. The pilot phase was also an excellent opportunity for Berlin Heart to supply feedback on the MDSAP from a manufacturer’s perspective.

What were your experiences in your first MDSAP audits?

The process of an MDSAP audit is very different from that of other audits. The audit model is strictly task-focused. The auditors address the ISO 13485 task by task––for example, design and development, management, service, etc. As the standard is processed task by task, some aspects may be scrutinized from several perspectives. During the audit, the auditors contact the specialist units for information not just once, but several times. For small companies like ours, this more dynamic process is what poses the actual challenge. The responsible employees must be available at any time throughout the entire audit, which quickly pushes companies to the limits of their resources. The total audit time is not much longer, but the audit model is new. During the audit, we are not asked more or different questions than in the individual audits held by the relevant regulatory authorities, yet the way in which the auditors address these questions is different. The MDSAP quite simply requires a lot of flexibility and mutual understanding from both our employees and the auditors. We have already concluded three successful MDSAP audits, and are thus the first company to have completed the entire audit cycle at TÜV SÜD. By now, we work together well and efficiently, also with TÜV SÜD. In our company, the MDSAP audit process is now stable and running smoothly. However, new issues have also come up in the meantime, for example regarding the application of the non-conformity grading of the GHTF (Global Harmonization Task Force, editor’s note).

Standardized audits are naturally every manufacturer’s dream. To what extent do you think this model could be expanded?

Furthering standardization is the responsibility of politics and the regulatory authorities. However, sometimes innovative companies do not want to – or cannot – wait until these parties take action. This year, we worked with TÜV SÜD to combine MDSAP and EU requirements according to MDD and AIMD in a single audit. Our quality management system already fulfills the requirements of the various countries involved. So why should we undergo two extensive annual audits in which most of the requirements overlap? This year, Berlin Heart underwent its first combined audit carried out by TÜV SÜD, and it worked very well. For us as medical device manufacturer, this combined audit proved extremely efficient and has further drastically reduced our audit costs and efforts. The opportunities TÜV SÜD offered us through this service set them apart from other organizations in the industry. It requires a very high level of expertise, both regarding MDSAP and the requirements for a wide range of medical devices. To put it in a nutshell, with the right partner, further standardization can be implemented already today. TÜV SÜD and its innovative approach have enabled us to make a quantum leap.

What conclusions can you draw from the MDSAP for Berlin Heart?

The result is great, and our experiences are highly positive. We can fully recommend the MDSAP to other companies! However, what ultimately counts for manufacturers is that they can enter and develop specific markets. Both the MDSAP and the combined audit offered by TÜV SÜD pave the way to do so.

What is your advice to other businesses which are now opting for the MDSAP?

Read the information that has been published on the MDSAP! The MDSAP requirements are set out very clearly and transparently, and allow companies to inform themselves in depth. Ask other companies that have participated in the program about their experiences! At Berlin Heart, we will be happy to share our thoughts with you. My clear recommendation would be to have the MDSAP in combination with MDD and AIMD performed by TÜV SÜD. The experts there know every detail of the program. I also consider it to be a major advantage that TÜV SÜD has the expertise and the testing facilities needed for registration of even the most complex medical devices. All these factors make TÜV SÜD our partner of choice, with which we, as a manufacturer, work well as a team and achieve results that are fantastic in every respect.

And on this positive note, we end our interview. Thank you very much, Mr. Heinze!

Berlin Heart

Berlin Heart GmbH is the only company in the world that develops, manufactures, and sells both implantable and external ventricular assist devices for patients of all ages and sizes with heart diseases. The INCOR®, EXCOR® Adult, and EXCOR® Pediatric systems provide short-term and long-term support for the cardiac function and are therefore a life-saving therapy option for the patients. Berlin Heart also offers clinical and technical support around the clock. With dependable and globally successful products, the Berlin-based company is one of the industry’s market leaders. Berlin Heart’s claim is to develop innovative solutions with utmost precision and reliability. The technological features of their products are unique. Future developments shall continue to meet the demands of the customers and the market. Berlin Heart is represented in the USA by its wholly owned subsidiary Berlin Heart Inc., which was founded in October 2005.

Georg Bauer

Georg Bauer

Department Manager Foreign Affairs

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