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Interview with Matthew Strege, IEC 60601 expert

We would like to get you all acquainted with our IEC 60601 expert. An interview where we talk about his expertise, how a normal workday looks like and which trends he observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!

Let's start with a small introduction, could you tell me something about yourself?

I was born and raised in the Midwest region of the U.S.. In appreciation of adventure, I’ve moved around quite a bit since graduating, including a decade living abroad in Japan. I’m a single father of a teenage boy and I enjoy that responsibility very much. I prefer cycling as my predominant means of transportation, exercise regularly and try to prepare healthy meals for my son and me. 

What is your main area of expertise?

I specialize in electrical safety, usability, and software for active medical devices meeting European medical regulations. However, I’m now working on broadening my knowledge and experience to include other regulatory markets.

Could you also tell me something about your experience before you joined Qserve?

The first 15 years of my career were primarily focused on electrical safety testing of active medical devices to international standards.

While there are a number of safety standards which can be applied to evaluate the safety of medical devices, IEC 60601 is the predominant standard family that is applied almost universally. So, for roughly 15 years, I evaluated a wide range of electrical medical devices against the 60601 family of standards. The devices would range from small, battery-operated devices like hearing aids, to large medical systems like MRI devices, CT Scanners, and even proton beam therapy systems which fill an entire dedicated building.

After 15 years of evaluations, I like to think that I’ve probably been involved in the evaluation of almost every type of electrical medical device known to medicine. To name a few more specific devices, I have experience evaluating: syringe and infusion pumps; positron emission tomography (PET) systems; Celution systems (for the transfer of adipose tissue); sphygmomanometers; anaesthetic respiratory systems; left ventrical assist device (LVAD); dental ultrasonic cleaners; fundus and retinal cameras; and robotic surgery systems.    

Where the last 5 years of my career were focused on reviewing technical files for compliance with European regulations with a Notified Body.

Which part of your job do you like the most?

I thoroughly enjoy those opportunities when I can help a client to understand regulatory/standard requirements or feedback from a regulatory authority so as to properly and appropriately address the requirements or concerns. For example, I recently helped a client understand the concepts related to the nonconformities they received from their notified bodies and helped to explain the background of the NC’s and how they can be addressed to satisfy the notified body.

How does a normal workday look like?

A project usually starts with a clients request, which can come in many various forms. Many of the manufacturers know they need a certification to market their medical device and are ready to submit their prototype for testing. Some manufacturers need more help understanding the requirements prior to implementing their design specifications to comply with the standards after development. Some manufacturers want assistance to understand the requirements of a standard and how to apply it to their medical device. And some want me to review the construction of their device prior to testing, to identify any gaps with the standard.

Becoming a consultant permits me more freedoms to side with the manufacturer with respect to their design aspirations and help them navigate any pitfalls and safety risks with their proposed design. With my experience involved with a wide range of electrical medical devices, I have seen how many requirements can be circumnavigated to comply with the standard. I have more freedom to make suggestions and counter-proposals when a design could be modified or rectified to meet a nonconformity.

On a normal day, I start my day by reviewing the emails that have come in from the previous evening from clients and colleagues in Europe and responding back as necessary. I often schedule client calls and meetings in the mornings, so I may have a couple of calls lined up to attend, while handling any urgent matters in-between. After lunch, I will come back and make progress on the projects assigned to me, aspiring to complete them in advance of expectations. Occasionally, a colleague will ping me with questions or inquiries that I might have insight or knowledge. Before finishing my work, I will check back with my email box for any additional emails that have come in during the day.

Do you prefer a specific type of medical device?

Due to my education and background, I have an affinity for active medical devices. Active devices always seem to have more interesting and stimulating functionality.

Which trends are topic at the moment?

Usability and stand-alone software seem to be the predominant trend at this time. There is perpetually more guidance coming out for the regulation of software, and artificial intelligence.

How do you stay up to date with everything that is happening in the MedTech-world?

I read newly published literature and guidance documents as much as I can in my spare time. I try to stay afloat with all of the regulatory changes that are taking place and new technologies that are coming through research on the internet and within Qserve.

What is your advice/message for our customers?

Qserve has an abundant wealth of knowledge and experience that can help facilitate entry into any market, resolution of disputes with regulatory authorities, or supplement your current regulatory and quality work force with apt resources who are eager to share what they know. Even if it’s a small task, the consultants are eager and happy to help you achieve your goals and market aspirations.

Would you like to know more about Matthew? Click here for his full profile.

Post date: June 17, 2020
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