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Medical Device MDR following new FDA Guidance

Event Details

Medical Device MDR following new FDA Guidance

Time: January 11, 2018 from 1pm to 2pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Phone: 1-844-216-5230
Event Type: webinar
Organized By: Sam Miller
Latest Activity: Dec 30, 2017

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Event Description

Description :
   This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include reporting requirements, record keeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using form 3500A.
Why :
   FDA Medical Device Reporting (MDR) regulations require firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so that they can be detected and corrected quickly. FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion by integrating the new Guidance information into the existing regulation. handout is CAPA flow chart
Areas Covered in the Session :
  1. MDR regulation,
  2. reporting requirements,
  3. report timing,
  4. when do you "become aware",
  5. record keeping requirements, form 3500A
Who Will Benefit:
  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers
  • Regulatory personnel
About Speaker:
   Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.
   Edwin Waldbusser has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
Price: 239$

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