The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.
Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software (and translation of software) are jut some of the major changes.
This audio conference covers:
- Status of MDD
- Overview of Changes & Ramifications including e-labeling, Authorized Representative, Evaluation & Post Market Surveillance, Drug/Blood/Human Tissue Engineered/Animal Tissue combination devices, Custom Made Devices & Annex VIII, Software, and Miscellaneous Issues
- Classification & Route to Conformity
- Clinical Data & Technical Files
- Compliance to Essential Requirements & Audits
About the speaker:
Eric Henning’s career started within a small division of Honeywell designing control systems. He then worked 7 years at a National Recognized Test Lab as a Project Leader testing devices and visiting many different electronics companies worldwide to assess design and production controls.
Moving back to the manufacturing side, Eric was the worldwide Compliance Manager for a division of ABB producing industrial and medical equipment for 6 years. Since 2000, Eric has been back to the regulatory authority side as a Senior Project Manager at the Notified Body KEMA focusing on active and active implantable medical devices in North America.
Eric has a BSEE from Virginia Tech, currently lives in Bucks County, PA, with his wife and two teenage children.
Who should attend?
- Compliance Officers
- Regulatory Affairs Manager/Director
- Clinical Project Specialists
- Auditors
- Risk Management Specialists
- Quality Assurance/Quality Control Personnel