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4th Annual European Device and Diagnostic Regulation Conference



 
Our Price: $495.00

Product Code: 2264
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About the Product
Includes presentation materials from the conference. Presentations slides are in PDF. format. All files are available for immediate download.


About the 4th Annual European Device and Diagnostic Regulation Conference:

Understanding the Evolving Status of the MDR & IVDR Framework as well as the Follow-on Impact on the Device & Diagnostic Industry & Notified Bodies, Addressing Concerns in Critical Supplier Transparency Requirements, while Balancing Current Regulatory Audits & Demands Worldwide


As the medical device and diagnostic industry across Europe continues to examine the evolution of the Medical Device Regulation and the In Vitro Diagnostic Regulation, and the eventual legal implementation of the regulations, organizations are at the same time preparing for enhanced regulatory requirements and an increasing number of both scheduled as well as unexpected regulatory audits. New changes in regulations continue to spiral towards increasing the amount of data required on-hand, as well as changing roles for Notified Bodies, Competent Authorities as well as Qualified Persons which need to be fully understood across the industry. On-top of union-wide regulatory changes, a number of individual member-states have also initiated internal regulatory changes which must be integrated into the regulatory landscape. From new product registration guidelines to the evolving use of UDI for tracking products across the world, medical device and diagnostic manufacturers had much to discuss and debate in this 4th Annual Medical Device & Diagnostic Regulation Conference.

Although the European Medical Device Regulations was an important part of the 2015 program, a particular emphasis this year focused on additional markets outside of the EU that continue to face regulatory changes and play an important role in the overall development of the medical device industry. Particular attention was paid to such markets including several Asian markets such as China, India and Japan, as well as rapidly growing South American regions and non-EU member states such as Russia. With so many regulatory changes to interpret and implement, manufacturers are looking for expert insights, which were delivered by a host of presenters including Notified Bodies, Competent Authorities and renowned industry executives.



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