Expert lectures on medical device compliance

Labquality Days 2023 has a lot to offer for medical device manufacturers and software developers as one of the main themes of the event is Developing Health Technology.

The annual congress is an excellent opportunity for you to meet the people who use your devices and software in their work.

In 2023, one of the biggest topics will be compliance. Get to know the expert lecturers covering the interesting topic below!


UDI – Universal confusion?

Miia Salonen
Development Manager
GS1 Finland

Miia Salonen has worked at GS1 for over 10 years and is a specialist in the benefits of the GS1 system. Her role as Development Manager is to support UDI compliance and drive the use of global GS1 standards in the healthcare sector. Her special interest is in bringing the standards to life, i.e. finding valuable use cases and benefits for industry and healthcare providers.

Key pain points in IVD technical documentations

Marta Carnielli
Head of Certification IVD
TÜV SÜD, Germany

Marta Carnielli is responsible for the certification process for IVD medical devices as well as ensuring that accreditations, designation and authorization relevant to IVDs are maintained by TÜV SÜD. She represents TÜV SÜD in regulatory committees, and conferences as well as supports management and technical experts with the interpretation of regulatory requirements. She is also the co-chair of the IVD Notified Bodies Working Group.

Clinical validity of legacy IVDs

Jari Martelin
Clinical Study Manager
Uniogen, Finland

Jari Martelin has two decades of experience in clinical microbiology diagnostics and has been actively involved in developing and testing of various IVD microbiology methods for diagnostic use. In the early years, he worked as a clinical microbiologist and was responsible particularly for the implementation and verification of molecular diagnostic methods and devices in routine use. Currently, he is responsible for the performance evaluation of newly developing assay products and their post-market surveillance studies at Uniogen.

The future of electronic quality systems

Filip Heitbrink
Co-founder and CEO
Scilife, Belgium

Filip Heitbrink is the co-founder and CEO at Scilife, the first Smart Quality Platform™ (for Life Sciences). An entrepreneur from a young age, Heitbrink’s ambition to continually be on the cutting edge of tech is unbreakable. Highly experienced in orchestrating state-of-the-art solutions for regulated industries, he is passionate about helping life science professionals around the world to make quality a smart culture, improve processes, and reach peak performance to drive value-creating outcomes.

elFU challenge

Clara Morgane
Reagent Labeling & Test Setting Team Leader
Stago, France

Clara Morgane joined Stago in 2010 and has been a part of the Labeling Department since 2011. She has experience in IVD labelling regulation and has since contributed to the implementation of the digitalization of IFUs at Stago.

 


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