managing your medical device reporting (mdr) program for

Having trouble viewing this Message? View it Online Best Online Trainings in Lowest Price Compare the Price with other Providers before you Register Aim to Train Maximum Professionals in the Industry Offering Trainings for All Industries Request our customers to give an opportunity to serve the best Live Webinar Managing Your Medical Device Reporting (MDR) Program for Compliance Success Date: Fri, July 10, 2015 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Instructor:David Dills Location: Online Register Now Overview: Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Areas covered in the session: What form should I use to submit reports of individual adverse events and where do I obtain these orms? How will I know if I require more information about my medical device report? Reporting device-related deaths and serious injuries and when these are not treated as a product complaint Understand the manufacturer's reporting requirements and expectations Are there exemptions, variances, or alternative forms of adverse event reporting requirements? Learn what constitutes a MDR and how to facilitate this for compliance success Develop, maintain, and implement written MDR procedures and achieve compliance Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that he agency deems no longer necessary Who Will Benefit: l levels of Management for all epartments and those who desire a tter understanding or a "refresh" erview A/QC egulatory Affairs and Compliance ngineering/Technical ervices/Operations onsultants About Speaker David Dills Regulatory Affairs and Compliance Consultant, David Dills Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an ...more Click here to register for this webinar Suggest a Topic More Webinars Compliance4All www.compliance4all.com 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from Compliance4All Click Unsubscribe

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Page 1: Managing your medical device reporting (mdr) program for

Having trouble viewing this Message? View it Online

Best Online Trainings in Lowest Price

Compare the Price with other Providers before you Register

Aim to Train Maximum Professionals in the Industry

Offering Trainings for All Industries

Request our customers to give an opportunity to serve the best

Live Webinar

Managing Your Medical Device Reporting (MDR) Program for

Compliance Success

Date: Fri, July 10, 2015 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes

Instructor:David Dills Location: Online Register Now

Overview:

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive

significant medical device adverse events from manufacturers, importers and user facilities, so

they can be detected and corrected quickly.

Areas covered in the session:

What form should I use to submit reports of individual adverse events and where do I obtain these

forms?

How will I know if I require more information about my medical device report?

Reporting device-related deaths and serious injuries and when these are not treated as a product

complaint

Understand the manufacturer's reporting requirements and expectations

Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

Learn what constitutes a MDR and how to facilitate this for compliance success

Develop, maintain, and implement written MDR procedures and achieve compliance

Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that

the agency deems no longer necessary

Who Will Benefit: All levels of Management for all

departments and those who desire a

better understanding or a "refresh"

overview

QA/QC

Regulatory Affairs and Compliance

Engineering/Technical

Services/Operations

Consultants

About Speaker David Dills Regulatory Affairs and Compliance

Consultant, David Dills Regulatory Affairs &

Compliance Consultant currently

provides regulatory, compliance and

quality consultative services for

medical device and

pharmaceutical/combination

manufacturers, and also has

an ...more

Click here to register for this webinar Suggest a Topic More Webinars

Compliance4All www.compliance4all.com 161 Mission Falls Lane, Suite 216,

Fremont, CA 94539, USA.

Phone: 800-447-9407 or

Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from Compliance4All Click Unsubscribe

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