Medical Device Reporting - Current MDR Regulations and Strategies to Implement FDA Final Guidance

Instructor: Rita Hoffman
Product ID: 705844
Training Level: Basic to Intermediate
  • Duration: 90 Min
This medical device reporting webinar will guide you to understand best practices to assess your current MDR efforts and implement changes to match the FDA's new guidance recommendations. Attendees will learn the current regulations that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for any device-related adverse events and certain malfunctions (investigational study reporting).
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Read Frequently Asked Questions

Why Should You Attend:

With the release of the finalized Medical Device Reporting (MDR) guidance on November 8, 2016, FDA has taken several positions that are in direct contrast to their previous opinions on the subject. Firms face new scrutiny from FDA on their complaint handling and reporting efforts. One of the top 3 inspection observations on an FDA 483 is lack of compliance with 21 CFR 803 (i.e., Medical Device Reporting), failure to make MDR determinations correctly and in a timely manner resulting in a large percentage of the Warning Letters issued by the FDA to US and Foreign manufacturers.

The MDR final guidance document itself is not an easy read, with 50+ pages of material outlining new positions that manufacturers consider when providing reporting obligations.

Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccurring. But, most manufactures do have a full understanding of what “Becomes Aware” meaning.

This 90-minute interactive webinar that will simplify the regulation and get grip on the final guidance. It will give you the tools to remain compliant or build top-notch compliance protocols.

Areas Covered in the Webinar:

  1. Overview of Medical Device Reporting and Complaint Handling requirements
  2. A breakdown of the changes from the draft to final guidance – what you must know, what is presumed, and changes in reporting timeframes
  3. Best practices to assess your current MDR efforts and implement changes to match the new guidance recommendations
  4. Strategies for continuous improvement
  5. What “Becoming Aware” really means – Ensuring your risks are mitigated
  6. Outside US Occurrence: Steps to handle unique reporting requirements
  7. Investigational Study Reporting

Who Will Benefit:

This course will be valuable to anyone involved in medical device complaint handling and MDR reporting, including everyone from phone teams, engineers, quality and compliance personnel, regulatory affairs, and upper management.

Instructor Profile:
Rita Hoffman

Rita Hoffman
Managing Partner, RHoffman Inc

Rita Hoffman is the Principal Consultant/Owner of Regs & Recall Strategies, LLC, and a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues. Ms. Hoffman has been consulting with FDA firms on post marketing issues for the past 6 years.

Ms. Hoffman spent more than 37 years with the FDA prior to retiring in 2011 she was the recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During Ms. Hoffman’s tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison, and policy analyst.

Ms. Hoffman has a diversified knowledge encompassing FDA scientific, investigational and regulatory policy and compliance areas due to her in-depth understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. Throughout her FDA career, she has provided guidance and clarified FDA requirements, to industry, foreign governments, public entities and FDA field personnel involving recalls, labeling issues, dietary supplements, pharmaceuticals, OTC drug products and combination products.

Ms. Hoffman, in addition to RAPS Certified, is the recipient of RAPS Special Recognition Award for her unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory affairs. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues. Ms. Hoffman holds a BS from the University of Maryland and has received many additional awards from both government and industry including the FDA Distinguished Government Service Award and Outstanding Service Awards for her Compliance work and industry contributions.

Topic Background:

What are MDR’s?:

Medical Device Reporting under 21 CFR 803 establishes the reporting requirements for device user facilities, manufactures and importers. It is a mechanism for the Food and Drug Administration to identify and monitor significate adverse events involving marked medical devices.

Follow us :
Managing Your Complaints and Obstacles in Post-Market Requirements
Medical Device Single Audit Program

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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