“The MDR has accompanied me ever since I’ve been at PMI”: Dr. Lisa S. on that and other large-scale projects in quality management and regulatory affairs

How long have you been with PMI?

Around three years in all, starting in 2017, then on parental leave and back since mid-2022.

What are your tasks?

I first worked in Quality Management, a very wide-ranging area in the medical device industry. Statutory requirements have increased exponentially in recent years, especially in the European Union. My task area very soon came to include Regulatory Affairs, in other words product approvals, because the work areas of QM and Regulatory Affairs are closely related and overlap in many areas.

Risk Class III medical devices, a category that includes our products, may only be marketed if we as the manufacturer have a complete QM system. The ISO standard of relevance for us is ISO 13485, which involves the design, safety and performance of a medical device.

And then of course there is the MDR, the Medical Device Regulation. It has accompanied me throughout my entire career to date at PMI. After we switched over to the new ISO 13485:2016 and had received the certificate—a major milestone for our team—the MDR was the immediate next item on the agenda.

When I returned from my parental leave our QM system was already converted to the MDR, but we had not yet gained CE certification subject to the MDR. The MDR approval for Suprathel was our 2022 Christmas present. We received the good news, our CE certificate, on December 21.

What have been your highlights at Polymedic Innovations?

There have been several. For one, the upgrade to the new ISO 13485:2016 standard. That required major process changes and innovations such as software validation, implementation of the risk-based approach, change management, etc. We were enormously proud when we finally received the ISO certificate.

The extent to which we have improved in QM over the past five years is evident in many other contexts. We recently had an audit by the FDA, the U.S. Food and Drug Administration, for example. The commission that audited us raised no objections. Dekra, our notified body, also pays us annual visits. In its last audit it raised just a few minor points even though the requirements are increasingly exacting. Our first audits five years ago were another matter entirely!

I am also really proud of the MDR approval. It took only three years for our rather small team. We also had to maintain the QM routine and international approvals. MDR is only for the EU, whereas we have other markets with approval criteria of their own, especially the U.S.

I have not even mentioned a “soft” highlight yet: my colleagues at PMI. The relaxed collaboration of the entire team across departments is most important for me personally. It motivates me when I would sooner stay in bed for a little longer in the morning.

What are your wishes for your career future?

For PMI I would like us to put the potential of our products to use in further application areas. Just as expressed in our vision: to revolutionize wound healing. If I could contribute toward that with my work I would be really delighted. Above all, when you have children of your own my profession has an entirely different sense of purpose, especially in view of our products.