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How to meet the Growing Challenges of Med Device Regulatory Compliance

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).

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?…
Recorded Mar 6 2019 44 mins
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Presented by
Volker Zeinar - B Braun, Grant Hodgkins - Smith & Nephew, Geraldine Lissalde-Bonnet - GS1, Jenny James - Innovit,
Presentation preview: How to meet the Growing Challenges of Med Device Regulatory Compliance

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Democratizing Master Data Management
Operating since 2000, Innovit is an end-to-end Master Data Management (MDM), Product Information Management (PIM), Global Data Synchronization (GDSN) and NPI Workfow solutions provider that is based in San Francisco CA with offices in London, Sydney and Melbourne. Innovit helps customers enhance revenue streams, reduce supply chain costs, improve online product marketing effectiveness, and ensure regulatory compliance.

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  • Title: How to meet the Growing Challenges of Med Device Regulatory Compliance
  • Live at: Mar 6 2019 3:00 pm
  • Presented by: Volker Zeinar - B Braun, Grant Hodgkins - Smith & Nephew, Geraldine Lissalde-Bonnet - GS1, Jenny James - Innovit,
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