Approvals and Clearances for Medical Devices Summit

With Recalls and Accidents on the Rise, FDA Guidelines for Medical Device Approval Increasingly Stringent

IQPC’s Approvals & Clearances for Medical Devices Summit gathers medical device companies to provide expert advice for efficient product approvals

Pharma IQ, a division of IQPC, announces the Approvals & Clearances for Medical Devices Conference, held February 27 - 29, 2012, at Metro Meeting Centers, Boston, MA. With new guidance documents being released by the Food and Drug Administration (FDA), many medical device companies are seeking clarifications and solutions to efficiently market their devices on time. The summit features presentations and workshops on current trends in the 510(k) approval process, expert advice for efficient product approvals, and networking with the aim of producing solutions to ongoing problems.

Approvals and clearances for medical devices have always been an important area of focus in the healthcare industry, and are a great challenge to product development. In a recent interview, Tom Hutchinson, Vice President, Regulatory Affairs, Davol Inc. noted, “The challenge is in the original market authorization submission to FDA, and then how you develop your systems in the most efficient and effective manner to meet the requirements.” Hutchinson goes on to discuss how best to do this in the interview, which is available here for download.

The presentations and workshops on the Summit agenda tackle realistic problems encountered by regulatory affairs professionals and build a powerful bridge of communication with the FDA. Some of the topics on the agenda include:

  • Practical knowledge and understanding of the 510(k) guidelines, including new guidance documents being released for Class I, Class II and Class III devices and how to abide by them for timely approvals and clearances
  • Development of plans to integrate regulatory affairs into the overall strategic plan of the company for a better understanding of the guidelines
  • Importance of time management throughout the product life cycle
  • Overcoming possible pitfalls through effective communication with the FDA

Featuring speakers from Siemens Healthcare Diagnostics, Access Scientific, Stryker Medical, GE Health Care, Abbott Point of Care and more, IQPC’s Approvals & Clearances for Medical Devices Conference features the latest updates from industry innovators blazing the trail towards successful approval:

For more information on the Approvals & Clearances for Medical Devices Summit please visit www.medicaldeviceapprovalsevent.com, or contact Ashley Rowe, Marketing Manager at Ashley.Rowe@iqpc.com.

About IQPC IQPC (www.iqpc.com) provides business executives with tailored practical conferences, large-scale events, topical seminars and in-house training programs. Producing over 1,500 events annually around the world, IQPC continues to grow and has offices in cities across six continents including: Berlin, Dubai, London, New York, Sao Paulo, Singapore, Sydney, and Toronto.