Eric Schwandt joined Medfiles in 2022 and works as a Medical Device Manager. In his current role, Eric leads Medfiles’ medical device and IVD operations while also working closely with client projects.
Eric holds a Bachelor of Science in Biology (1993) and a Master of Science in Oral Biology (2002). His academic path initially led him towards dentistry, but a growing interest in molecular biology and the pathology of oral cancer shifted his focus to biomedical science – an interest that later developed into a career in the medical device and diagnostics field.
Before joining Medfiles, Eric spent more than 20 years in the medical device and IVD industry, working in a wide range of roles covering regulatory affairs, quality management systems (QMS), and marketing.
Supporting clients with broad regulatory expertise and perspective
At Medfiles, Eric manages client projects and leads a team of Medical Device and IVD Experts. He also acts as a Senior Expert within the team. His work centres on guiding clients through regulatory strategy and preparing the technical documentation needed to successfully implement those strategies across different markets and regulatory frameworks.
Over the years, he has worked as a Quality Manager for an IVD company, a Marketing Manager responsible for point-of-care diagnostics, and a Regulatory Manager overseeing international registrations of X-ray equipment.
“This long experience in different roles within the medical device industry allows me to view each project from multiple perspectives, always with a strong focus on our clients’ needs and practical outcomes.”
His academic and professional background has also led to particular expertise and interest in areas such as autoimmune disease diagnostics, point-of-care (POC) testing, immunohistochemistry, as well as radiation and laser product safety.
Leveraging expertise in every project
Eric values the depth and breadth of expertise at Medfiles. Working alongside colleagues with varied backgrounds means support is always available, and every project brings something new.
“I like working with colleagues with a wide variety of experience and expertise – if I don’t know something, someone who does is close at hand.”
“Every project is different, and working at Medfiles allows me to leverage expertise gained at all points of my career – whether it is molecular diagnostics, ISO 60601 electrical safety, FDA 510(k) applications or preparing for a Notified Body audit.”
If your company lacks the necessary expertise or resources, Medfiles’ medical device and IVD experts are on hand to assist with both large and small projects. You will receive comprehensive expert services covering the entire product lifecycle, from establishing a quality management system (QMS) to post-market surveillance (PMS).
