Recorded Seminar Online

US Laws and Regulations for Medical Devices Including In Vitro Diagnostics (IVDs)

Law Book
US Laws and Regulations for Medical Devices

About the Seminar

The recorded version of this online seminar is available for the purchase below.

  • It is about 78 minutes of duration.

This seminar is intended to help global healthcare industry professionals get familiar with US laws and regulations governing medical devices. In particular, this seminar will discuss regulatory requirements applicable for various different types and classes of medical devices.

In this 60-min presentation, the speaker will guide you through the details of what is required to obtain US FDA approvals or clearances for medical devices.

This has been helpful for those preparing for the US Regulatory Affairs Certified (RAC) exam.

Testimonials

  •  It was perfect! It was thorough yet broad enough to encompass all of the important points on the subject matter. I liked your presentation: very nice flow and explanations! – by Regulatory Affairs Manager
  • It’s a very nice spearheaded presentation, “real time saver”! – by Program Development Manager

About the Areas to Be Discussed

  • US Laws and Regulations Governing Medical Devices
  • Definitions
  • Medical Device Classification
  • General Control and Special Control
  • Medial Device Panels
  • Label and Labeling
  • Clinical Trial Requirements and IDE
  • 510(k)
  • PMA
  • HDE
  • Quality System Regulations (cGMP)
  • Postmarket Requirements
  • Guidance Documents and Standards
  • Practical, Actionable, and Sustainable Solutions (PASS)
  • Speaker’s Recommendations for Best Practices based on Actual Cases

About the Intended Attendee(s)

  • Regulatory affairs
  • Marketing
  • Clinical Affairs
  • Quality
  • Legal Counsel
  • Compliance Officers
  • Consultants
  • Regulatory Agency Personnel
  • Any Professionals Interested in the Topic

About the Seminar Speaker

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Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight (8) years.

Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Purchase Options

  • Option 1: you may send your “Request to Purchase” or “Purchase Order by email to sales@globalcomplianceseminar.com
  • Option 2: you may request an invoice by email to sales@globalcomplianceseminar.com
  • Option 3: you may purchase below using a credit card or PayPal.
    • Recorded: $249
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