Combo Pack of 5 Best Webinars on "Medical Device Reporting"

Medical Device Reporting is the means by which adverse events and malfunctions with medical devices are reported to the FDA. Under the Safe Medical Devices Act of 1990, device manufacturers, importers and user facilities must report known device-related deaths to the FDA.
Instructor: David Lim, Casper Uldriks, Jerry Dalfors
Product ID: PACK70019

Medical Device Reporting was implemented in order to furnish the FDA with the information obligatory to detect and correct medical device failures and establish safety in the healthcare industry.

This pack of 5 courses contains some of our best selling Medical Device Reporting webinars which jointly cover the all-important compliance challenges faced by Medical Device organizations today.


CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

CEOs | VPs | Director | Clinical Affairs | Regulatory Affairs | Quality | R&D | Consultants | Contractors/Subcontractors


Webinars included in the Package:

Best Practices for MDRs, Recalls, Corrections, and Removals (Duration: 60 Minutes)

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. This webinar is intended to help device industry establish adequate procedures for MDRs, recalls, corrections and removals and further to provide practical, actionable, and sustainable perspectives by increasing awareness and familiarity of the applicable requirements. At the end of the webinar, you will leave actionably motivated in a way that you would plan, develop and execute the relevant procedures in a holistic manner.

Objectives of the Presentation:

  • Applicable statutes and FDA regulations
  • Regulatory requirements for MDRs, recalls, corrections and removals
  • Definitions
  • How to report medical device adverse events
  • Reporting requirements for the user facilities, manufacturers, and importers
  • Recalls, corrections and removals (devices)
  • Voluntary recalls and mandatory device recalls
  • How to perform and document corrections and removals
  • Checklist
  • Enforcements: case studies

Instructor Profile:

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009,

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Implementing Medical Device Reporting (Duration: 60 Minutes)

This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting. In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required 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 they can be detected and corrected quickly. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR to survive FDA inspections - avoiding FDA 483s and warning letters.

Objectives of the Presentation:

  • Applicable Statues, US Codes, and MDR Regulations
  • Definitions
  • MDR Regulatory Requirements
  • MDR Standard Operating Procedures (SOPs): Required Elements
  • MDR Criteria
  • Determining and Reporting MDR Events
  • Reporting Requirements for the User Facilities, Manufacturers, and Importers
  • Enforcements: Case Studies

Instructor Profile:

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009,

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Changes in FDA's Device Corrections and Removals Reporting (Duration: 60 Minutes)

FDA's original implementation of the Corrections and Removals under the Safe Medical Devices Act of 1990 required firms to report a Class I or Class II recall to FDA. The FDA health risk evaluation criteria were the same for Medical Device Reporting. Firms were not required to report Class III recalls or product enhancements under either regulation. Likewise, firms were not required to report product enhancements or design changes. This meant that design enhancements were not per se subject to reporting. Design enhancements were managed under the Quality System regulation. How firms will manage the change in FDA's reporting requirements is unclear but the consequences are significant.

Objectives of the Presentation:


You will understand the difference between existing device recall reporting requirements and those under FDA'S proposed changes. Understanding the proposed changes will give you a practical guide as to what you may need to revise in your current health risk procedures and design change assessment. You will be able to provide an initial explanation to your firm about the impact of FDA's proposed changes on product liability considerations.
  • What are the current recall reporting requirements?
  • How has FDA broadened recall reporting requirements?
  • How would the change affect your health risk assessment criteria for the Medical Device Reporting regulation?
  • What are the business consequences for reporting proprietary information?
  • How would the change affect a firm's FDA risk assessment procedure and product liability considerations?

Instructor Profile:

Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.

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Medical Device Reporting (MDR) (Duration: 90 Minutes)

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 reoccur.

Objectives of the Presentation:


  • Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).
  • Evaluation of suppliers, contractors, and consultants. Each manufacturer is required to establish and maintain the requirements, including quality requirements as well as a quality agreement, that must be met by suppliers, contractors, and consultants. Each manufacturer is expected.
  • How parties involved in the contract manufacturing of drugs or medical devices can utilize Quality Agreements to delineate their responsibilities and assure product quality, safety, and efficacy. This guidance applies to the commercial manufacturing of FDA regulated raw materials, final product components, intermediates, combination products or final products. For the purposes of generating the agreement, the term "manufacturing" includes processing, assembly, packing, holding, labeling operations, testing, and operations of the vendor's Quality Unit.
  • Purchasing data. Each manufacturer must establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents typically include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.
  • Identification - 820.60 - Each manufacturer must establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix ups
  • Traceability - 820.65 - Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user are required to establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures are intended to facilitate corrective action. Such identification is to be documented in the DHR
  • Control of nonconforming product. Each manufacturer must establish and maintain procedures to control product that does not conform to specified requirements. The procedures are required to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance must include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation has to be documented
  • CAPA - Before non-conformance or deviations are discovered, we also have to have an Incident Tracking system, which is used to determine when Corrective Action or Preventative Action needs to be applied - Quality Evaluation, Investigation, Root Cause Analysis, Change Management, Effectiveness Monitoring and Acceptance
  • Each manufacturer is required to maintain a quality system record (QSR) for each batch or lot. The QSR will include, or refer to the location of, procedures and the documentation of activities required for the production of the product that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer is required to ensure that the QSR is prepared and approved in accordance with 820.40 as well as the Quality Review documentation used for release
  • Each manufacturer must maintain complaint files. Each manufacturer needs to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures are intended to ensure that.

Instructor Profile:

Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

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Establishing a Medical Device Reporting System Integrated with a UDI System (Duration: 60 Minutes)

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, deaths or serious injuries 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 they can be detected and corrected quickly. It is critical to accurately interpret and understand MDR regulations, and in particular, how to precisely define, document and implement MDR procedures to achieve compliance and to remain compliant with the MDR regulations in a sustainable manner.

Objectives of the Presentation:


  • Overview of Relevant Laws and Regulations
  • Definitions
  • Regulatory Requirements for MDR Procedures
  • How to Report A Medical Device Problem (MDR)
  • Reporting Requirements for the User Facilities, Manufacturers, and Importers
  • Relationships with Adverse Event Reporting Systems in EU and Health Canada
  • UDI System Integration
  • Enforcements: Case Studies
  • Conclusion

Instructor Profile:

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009,

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