Drawing on regulatory and clinical experience, the session will address how these requirements interconnect within the technical documentation, current expectations under ISO 10993-1, MEDDEV/MDCG clinical evaluation guidance and ISO 14971 and practical strategies for building a coherent, audit ready evidence package. The session is geared towards regulatory affairs, quality, and clinical professionals working on MDR technical file. 

What you'll learn:
- Understand the key MDR requirements for biocompatibility, clinical evaluation and risk management under Annexes I, II and III
- Learn how to integrate these three workstreams into a coherent, audit-ready technical documentation package
- Gain practical insight into current notified body expectations and common compliance pitfalls
- Discover practical strategies for preparing and maintaining robust MDR technical documentation that supports regulatory compliance

Who should attend:
This webinar is intended for regulatory professionals, quality assurance specialists and clinical affairs personnel involving in preparing and maintaining MDR technical documentation as well as start-ups and SME teams seeking a practical introduction to these interconnected requirements. 

Your presenters: 
Jana Brajdih Cendak - Medical and Pharmacovigilance Lead/Medical Adviser/Eu QPPV
Stasa Taferner, PRRC, Regulatory Affairs

Jana started her career as a practising physician, specialising in emergency medicine. After almost 10 years in medical practice she joined Sanofi's medical affairs team covering southeast and central Europe. Following a short transition to Novo Nordisk, she moved to Billev Pharma East, a consultancy company based in Slovenia. In her current position Jana is responsible for a team of pharmacovigilance specialists, medical advisers and veterinary medicine advisers covering human and veterinary pharmacovigilance and providing regulatory support to clients. She is currently more involved in toxicology after finalising an MSc programme in Toxicology at the Vienna Medical University and in the process of obtaining the European Registered Toxicologist certificate.  She is an active member of various industry associations including ISOP, EUCROF and Medicines for Europe.

Stasa started her career in regulatory affairs working with human and veterinary medical products in Europe and the UK. She later broadened her role by expanding her expertise to include the regulatory affairs of medical devices across the USA and EU. Today she supports clients across the pharmaceutical and medical device sectors with a particular focus on regulatory strategy, guiding products through the registration process and driving post-approval lifecycle strategy and regulatory maintenance across the UK and EU.

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