This webinar offers understanding on the provisions of the 21 CFR 803 MDR program.
Online PR News – 01-July-2015 – Fremont – Compliance4All announces webinar on the topic, “Managing Your Medical Device Reporting (MDR) Program for Compliance Success” on July 10. This webinar offers understanding on the provisions of the 21 CFR 803 MDR program.
Fremont, CA: Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, will organize a webinar on July 10. The topic of this webinar is “Managing Your Medical Device Reporting (MDR) Program for Compliance Success”. The speaker at this webinar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant.
About the webinar:
This webinar will provide valuable assistance and guidance to all medical device companies and user facilities that are required to manage or comply with the provisions of the 21 CFR 803 MDR program.
For more information or to register for the webinar, please click here.
Medical Device Reporting (MDR) is the mechanism of the Food and Drug Administration (FDA) by which significant medical device adverse events from manufacturers, importers and user facilities are received, so they can be detected and corrected.
This webinar acquaints participants with this mechanism, which is spelt out in the 21 CFR 803 MDR program. The need for tracking of adverse events from medical devices has become pronounced in view of the fact that there is all-round underreporting, despite the requirement, which has been in place from as long back 1984, that manufacturers and importers of medical devices have to report to the FDA all device-related deaths, serious injuries, and certain malfunctions.
Following the discovery of underreporting; the FDA enacted the new, more powerful regulation on MDR on July 31, 1996. This is the current regulation for user facilities and device manufacturers. The speaker at this webinar will offer learning on this regulation.
About the Speaker:
David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.
Compliance4All (http://www.Compliance4All.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. Compliance4All offers a broad range of high quality, affordable regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.
Many professionals in the various areas in which Compliance4All offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.