Medical Devices: Navigating FDA Requirements for Non-US Organizations


Instructor: Jonathan Lee
Product ID: 705823
Training Level: Basic

  • Duration: 90 Min
This webinar will give an understanding of various processes and compliance requirements for US market entry by non-US medical device manufacturer. It will teach how to comply with pre-market requirements, how to get submission & product clearance/approval, what are various activities to be done post market entry of products (surveillance, reporting, audit, correction & removal).
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Why Should You Attend:

The US Medical Device market is valued at over $US150Billion annually. Entering this market requires satisfying a myriad of regulations dominated by the Food and Drug Administration – FDA.

And, there are extra requirements that need to be satisfied by non-US organizations. Avoiding FDA pitfalls by knowing the FDA requirements and expectations helps overcome these challenging barriers to entry.

Attend this 90 minutes webinar to get an executive summary of the requirements to be met – both obvious and not so obvious. Introducing real world experience brings the theoretical into the practical.

Various requirements beyond the 510K for US market entry of medical devices are

Quality System requirements (CFR 820 cGMP), Medical Device Reporting (803), Corrections, Removals, Recalls ( 806, CFR Part 7: Recalls – part of CFR (Aug 2018 update)
Product submission ( Product classification: I, II, III, Product Code, 510(k) and product clearance, PMA and product approval, IDE & Clinical data)
Auditing ( Initial Site audit, Surveillance audits, MDSAP), Registering (Establishment Registration & Device Listing, American Agent)
Ancillary requirements: Part 11, UDI, HIPAA
Assistance and help: Small Business Office, DICE & CDRH Learn

Areas Covered in the Webinar:

Market entry & maintenance requirements:

  • Pre-market Requirements - activities before product enters the market:
    • Establishment registration & Listing
    • Quality system audit/certification
  • Submissions & product clearance/approval
  • Post market requirements - activities after product enters market:
    • Post market surveillance – complaint handling
    • Medical Device Reporting
    • Surveillance audits
    • Corrections & removals

Who Will Benefit:

  • Global Business Development & Marketing personnel
  • Regulatory personnel responsible for planning and satisfying FDA requirements
  • Compliance and regulatory submission personnel responsible for satisfying site audit and submission review.
  • Medical device organization employee seeking an overview of FDA regulations and compliance requirements, from such groups as:
    • Compliance
    • Quality Assurance
    • Purchasing/Supply Chain
    • Clinical Affairs
    • Manufacturing & Production
Instructor Profile:
Jonathan Lee

Jonathan Lee
President, Medical Device Consulting Solutions

Jonathan Lee is the President of Medical Device Consulting Solutions International serving clients both within and outside the US.

An early career in Class III Medical Devices in Australia and now located in the USA, Mr. Lee has extensive personal experience with FDA from product submission, product amendment, site audit, field action, to end of product life. This experience, gained over 35 years, involved working with both US based and out of US (OUS) based organizations.

A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic.

In addition, his consulting roles include supporting: implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation systems, surgical tools, vertebral stiffness measuring systems, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, clinical study management and product clearances & approvals.

His success has been shared through participation in webinars, seminars, and presentations including being an invited speaker to the Association of Food and Drug Officials (AFDO) and conference participation in compliance symposia at Harvard University and serving as an instructor on Quality Systems at the University of Southern California School of Pharmacy Master’s Degree Program.

Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University.

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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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