SPARK Educational Forum: REGULATORY CONSIDERATIONS FOR CLINICAL DEVICES

WOLFGANG WERNER, BIOVOTION AG

CHRISTINA DEGEN, BIOVOTION AG

Regulatory Compliance is one mandatory requirement for approval of products including
drugs, medical devices and diagnostics, to ensure their market entry. The
“good practice” (GXP) guidelines span the entire development process from the acquiring
of unbiased data in the lab and keeping this data well documented, to production
under Good Manufacturing Practice (GMP) conditions and conducting of
clinical trials following Good Clinical Practice (GCP) guidelines. The goal is clear: to
generate safe and effective products for patient needs.

In this forum we want to focus on the regulatory requirements for medical devices
and what is needed to bring them to market. Importantly, the thinking behind the
process is very similar to any other compliance philosophy: the more thorough the
planning and the better documented the process, the better the rationale and the
more reliable the outcome results. All for the best of the patient.
In the overview lecture, Wolfgang Werner from Biovotion AG will present the relevant
guidelines and principles. The aim is to give a perspective of the general requirements
and why they are in place, as well as what will change with the most recent
regulatory updates.
Wolfgang is an engineer with profound international experience in regulatory affairs
and quality management from the medical device industry. He has held positions at
Berlin Heart, TÜV Süd, Terumo Heart, and worked with startups in the eHealth and
mHealth area.

The second lecture will be presented by Christina Degen, regulatory and quality specialist
at Biovotion AG. She will give us ample examples on the process from the
practical point of view, including examples from both industry and startups.