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:
Why the European regulations are changing
An overview of the text being voted on
What does the new regulation mean for manufactures
Examine the risk based approach to classification
Strategy for technical documentation preparation
Changes to clinical evidence for devices
Post market surveillance and vigilance for medical devices
What you can do to start preparing now
What are all the significant changes
*Note: Limited live seats available.
Medical Device Executives and CEOs
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
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.
Greenlight Guru is the only Quality Management Software built exclusively for the unique needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit our home page to learn more.
Our aim at Acclaim Biomedical Consulting (ABC) is to provide you with an independent, pragmatic approach to meeting the ever changing regulations of the healthcare and biomedical industries so that you can manage your business successfully. By using our network of expert consultants, associates and partner companies we can bring together decades of relevant experience – from quality assurance and clinical research to product design and market development. Click here to learn more.