New Start For Clinical Trials For Medical Devices

Main Category: Clinical Trials / Drug Trials
Also Included In: Medical Devices / Diagnostics
Article Date: 16 May 2011 - 1:00 PDT

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The Medical devices sector is currently one of the fastest growing areas within life sciences, experiencing growth of around 11% between 2010 and 2011. However, development in this sector is broadly influenced by the strict regulation, which is continually evolving . Recently updated regulations such as ISO : 14 155 : 2011 have influenced the industry in many ways, and created new challenges for Medical Device and even Pharma companies with combination products. Their proper understanding and implementation, within the industry's regulatory and clinical departments is vitally important to building future competitive advantage.

To face the challenges of this environment, companies have to be familiar not only with local regulations, but also with those of the EU, the US, and those present in the vast expanse of the global marketplace. Acknowledgment of this complexity has a huge influence their business. Harmonized regulation between the major markets of the EU, US and Japan are not yet in place, however intense discussion has been ongoing. Get perspective, an update on the US FDA's 510 (k), a regulation that deals with "fast track" submission of medical devices, and could effect not only US devices but can impact European ones as well.

To Respect national law, international regulations and standards are just a pillar of the success. Innovation, and deep knowledge of the markets and investments that lead to a company's success. Emerging markets in China and Latin America attract investments, but how about pitfalls and responsibilities? How can we transfer our best practice abroad, for safety, innovation, and productivity?

These and many other related topics will be discussed and brainstormed at 2nd Annual Clinical Trials for Medical Devices with leading industry representatives such as:

- Founder, Medical Device Strategies, WMDO
- Director Clinical Affairs Europe, ev3 (Covidien)
- Director Clinical Affairs, GE Healthcare
- Senior Medical Director, Boston Scientific
- President and Founder, Applied Research Consortium of Asia Ltd.

who will share their best practices, offer their expertise on recent developments in regulation, and discuss other practical issues during the interactive debates.

Source:
Fleming Europe

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