How to meet the Growing Challenges of Med Device Regulatory Compliance
Volker Zeinar - B Braun, Grant Hodgkins - Smith & Nephew, Geraldine Lissalde-Bonnet - GS1, Jenny James - Innovit,
Seven years ago when the Federal Drug Administration (FDA) announced its Unique Device Identification (UDI) regulations, there were no off-the-shelf solutions for submitting regulatory data to the Global UDI Database (GUDID).
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Now these options exist, so how will this influence your approach to Medical Device Regulations (MDR)? How would you do things differently for MDR and UDI, specifically European Databank on Medical Devices (EUDAMED)? Our panel of experts will weigh‑in on:
- How this is a key priority for global medical device manufacturers.
- Whether this is it just the structured master data or more?
- What about forms and documents like: post-market vigilance and surveillance, clinical investigations and performance studies, actor registration, notified bodies & certificates?…