Medical Device Webinar Series

The webinar sessions are a series of 4 different topic presentations (15-20 minutes with 5 minutes Q&A portion) and held every month. They provide short insightful hints beneficial to those in the medical device market and can lead to offline discussions with expert resources. The presentation recording and the rest of the answered questions will be posted on our website.

1. Click to access video and PDF slide deck

   Does your Quality System meet the demands of medical device market?

   Note: This webinar is now closed – Click here to access the recorded webinar and powerpoint document
   December 7, 2010, 11:00am PST

   This webinar gives a brief introduction and differences between ISO 9000, ISO 13485 and FDA QSR. It provides medical device OEMs and their suppliers a checklist comparison of quality systems and regulatory requirements. Medical device OEMs can pinpoint areas in their suppliers Quality System that need upgrading to the level demanded by regulatory requirements.

   Presented by: Cochise Mapa, Director of Business Development for Emerson
2. Click to access video and PDF slide deck

   Are you ready for IEC 60601-1 3rd Edition?

   Note: This webinar is now closed – Click here to access the recorded webinar and powerpoint document January 25, 2011, 11:00am PST

   This webinar provides an overview of differences between the 2nd and 3rd editions. It provides practical examples of implementing the 3rd edition. Medical Device OEMs can begin preparation to become compliant before time runs out by June 2012 deadline.

   Presented by: Dan Modi, Director, Standards Certification and R&D Quality, Alcon Surgical
3. Click to access audio and PDF slide deck

   What can medical device OEMs learn from the electronics industry?

   Note: This webinar is now closed – Click here to access the recorded webinar and powerpoint document February 8, 2011, 11:00am PST

   This webinar illustrates some programs and strategies typically used by electronics manufacturers in addressing the design controls, purchasing controls, production/process controls & post market surveillance issues in the regulated medical market. Medical device OEMs can appropriately adopt such success strategies to be successful in this similarly competitive medical market.

   Presented by: Cochise Mapa, Director of Business Development for Emerson
4. Click to access audio and PDF slide deck

   Meeting custom requirements using standards solutions: How do you go there?

   Note: This webinar is now closed – Click here to access the recorded webinar and powerpoint document March 15, 2011, 11:00am PST

   This webinar does a cost/benefit analysis of using standard components versus custom-made components in light of medical device products and risks. The examples used are power supplies but are applicable to other components. Medical device OEMs can take advantage of using standard "building blocks" components for their custom solutions with less risk and problems.

   Presented by: Chris Jones, Marketing Director