Massive changes are afoot in global regulatory and quality requirements for the medical device industry, including the European medical device and in vitro diagnostics regulations, new clinical evidence requirements, updated standards, and mandatory participation in the MDSAP program for those wishing to distribute products in certain markets.
Manufacturers need not only to change current procedures but to evaluate and remediate legacy products that will remain on the market. There are phase-in periods for the new requirements, but they are never as long as one might like, and there are always unanticipated complications and delays.
Strategic planning, assessment of products and procedures, and the design and implementation of new SOPs are complex, costly, time-consuming activities. And there will be fewer and more overworked notified bodies to assist companies in the future.
In this highly interactive conference, the two largest and most experienced notified bodies, together with experts from companies well advanced in planning for the upcoming changes, present the issues and requirements, experience, and best practices for efficient compliance and remediation.
Who should attend:
Medical device and IVD professionals in:
What you will learn :
Hogan LovellsWashington, DC 20006USA555 13th Street
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