Medical Devices: From Idea to Market

US and European Regulatory Requirements and Clinical Evaluation Strategies (course code 113)

Dates : Monday-Tuesday, 4-5th July 2011

Venue: Biopolis Singapore

8 CPE Points awarded by the Singapore Pharmacy Council

Medical device regulations are evolving as the design of new devices becomes more complex. Since 1993, Europe had regulations in place, and since then, there had been many updates with the latest in March 2010 bringing significant enforcement text with it.

In this fast growing medical device market, with relative short product life, getting products through development and validation in a compliant manner for a worldwide market is crucial for the survival of a company. Many companies are eager to find the most direct and efficient regulatory path to a worldwide market while trying to keep up to date with constant changes by the regulators, making it essential that all parties have the necessary cross functional know-how so that a team can work efficiently together. Understanding the basics of medical device regulations leading to the right strategies is essential. A quality assurance professional needs to understand what is involved in the regulatory and clinical side so as to support these functions efficiently, likewise clinical and regulatory professionals need to have the necessary insight in each other's specialty requirements so that conformity to the essential requirements for a medical device can be met. Last but not least, business and marketing managers need to come to grips with the requirements to have the right marketing strategy for their product and company.

This two day course will provide an overview of the medical device regulatory system worldwide while going in depth on the European system and providing a worldwide clinical strategic view presented from different specialty angles so as to point out the cross functional interactions between the different industry functions.

In collaboration with : A*STAR Healthcare and Lifestyle Programme and WMDO

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