Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) earlier this year.
This represents the single largest regulatory change in the EU in decades and it will affect ALL device manufactures selling in Europe.
The new European MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
Join us for this free, 90 minute webinar presented by our guest Richard Young, Managing Director at Acclaim Biomedical Consultants, where he will be sharing will you in detail what all the significant changes are and how you can begin preparing for compliance now.
SPECIFICALLY you will learn:
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Why the European regulations are changing
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An overview of the text being voted on
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What does the new regulation mean for manufactures
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Examine the risk based approach to classification
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Strategy for technical documentation preparation
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Changes to clinical evidence for devices
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Post market surveillance and vigilance for medical devices
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What you can do to start preparing now
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What are all the significant changes
*Note: Limited live seats available.
who should attend?
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Medical Device Executives and CEOs
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Regulatory Affairs Professionals and Management
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Quality Professionals and Management
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Clinical Affairs Professionals and Management
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R&D Engineers and Management
about the presenter:
This webinar is being lead by Richard Young, founder and managing director at Acclaim Biomedical Consulting Ltd.
Richard has worked in the Medical Device and In Vitro Diagnostic markets for over 25 years with a personal focus on regulatory compliance, process validation and risk management.
Richard has been an active member of many groups through his time in industry, including representing industry in the formation of the “beyond compliance initiative” and spending many years on the Eucomed Standards Focus Group as well as standards groups such as LBI 35.
Over the last few years, his consulting activities have included a large proportion of training and education including teaching at Sheffield Hallam University in the UK on a Post Graduate Diploma Course.
