Between the COVID-19 pandemic and BREXIT negotiations, the rapidly approaching deadlines to comply with the new In Vitro Diagnostics Regulation (IVDR) may have a profound impact on market access to products and, ultimately, patient outcomes. Now more than ever, in vitro diagnostic manufacturers will need to prepare for the upcoming changes to the clinical and regulatory landscape.
Understanding current guidance and adapted regulations is the first step to navigating transformations the diagnostics, and broader healthcare industries are undergoing.
Join us to learn about today’s IVD regulatory landscape and discuss how manufacturers can develop strategies to ensure a successful transition to comply with the IVDR by the 2022 deadline, including:
- Overcoming the shortage of NBs
- Assessing product portfolios and quality systems
- Planning and implementing technical file remediation
- Managing the IVD lifecycle
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Anyone involved in the medical device or IVD industries, including medical device manufacturer personnel from: R&D, Clinical Operations, manufacturing, quality assurance, regulatory affairs, sales/marketing, Executives, directors, product managers, senior managers, clinical research staff & scientists.