The new EU Medical Device Regulation (MDR) promises to improve product quality and safety by relying more on clinical evaluations and data, even for devices that have been on the market for a long time. The MDR will replace the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) in May 2020.
Manufacturers must thoroughly assess all product portfolios, ensuring all clinical, regulatory and quality data are complete and traceable. This task is costly and time-consuming and becoming increasingly frustrating as the deadline draws closer.
How can device manufacturers prepare for the new EU MDR? How will this change business operations? How will the new EU MDR impact the future of medical devices?
These five Xtalks webinars have all the answers. Register for free to watch each informative presentation!
A market analyst and a senior manager consultant discuss key strategies on how to achieve EU MDR compliance using a staged approach, become an EU MDR pioneer and seize market share. Together, both speakers bring over 40 years of experience in the life sciences and regulatory industries to help manufacturers get ahead of the competition.
Xtalks Partner: Kalypso
Global clinical research company ICON hosts a webinar about key changes pertaining to the MDR and the In Vitro Diagnostic Medical Device Regulations (IVDR), which is set to take effect in 2022. The featured speaker discusses the importance of early planning and how it may lead to a market advantage plus how to prioritize a product portfolio. The speaker has over 20 years of experience in regulatory affairs, clinical studies and research & development in the medical device and in vitro diagnostics device industries.
Xtalks Partner: ICON
In this free webinar, experts from Premier Research answer all your questions, from the most basic to the most advanced:
- Is it possible to avoid compliance with the MDR?
- When should I be compliant?
- How will this affect my new product development?
- How does this affect my products currently on the market?
- Which notified body should I use?
- How will Brexit affect my company?
- Where do I begin?
This webinar will provide an overview for those still unfamiliar with the new regulations, plus cover specific topics like gap analyses, communicating with a notified body and adopting MDR within allotted timelines.
Xtalks Partner: Premier Research
The diversity of speakers makes this webinar worth attending. Expert speakers include a clinical evaluation lead from device company HILLROM and a clinical reviewer from one of the four MDR notified bodies, TÜV SÜD. Dr. Derek Arts, founder and CEO of Castor EDC turns the daunting task of preparing for the new EU MDR into six essential steps for success.
Xtalks Partner: Castor EDC
Learn about why and how the new EU MDR regulations came about, how to take appropriate steps to ensure you’re prepared and why the emphasis on clinical evaluations and investigations matter in this informative webinar. The featured speaker has over 35 years of experience in medical device design, development, quality and manufacturing and provides design control consulting services through her new start-up. Attendees will leave with a greater understanding of what the new regulations entail and how it will impact the medical device industry.
Xtalks Partner: Medrio