Webinar on Medical Device Regulatory intelligence

Instructor: James W Monroe
Product ID: 706457
Training Level: Intermediate
  • Duration: 60 Min
This webinar will demonstrate methodologies for obtaining competitor information to use for the establishment of equivalence. You will also learn how to monitor changes in the global regulatory medical device landscape.
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Read Frequently Asked Questions

Why Should You Attend:

  • Do you know new EU MDR regulations and requirements for Equivalence?
  • Do you market devices in countries that establishing medical device regulations?
  • Are regulation in countries you have registered devices changing

As the global regulatory landscape continues to rapidly change it is important for the regulatory professional to provide companies/client with up to date information on competitors and requirements to register their products in various markets. This webinar help to define the word intelligence as it relates to medical devices. Further the participant will learn various ways to conduct research on competitor devices, how to use MedTech online daily newsletter and Health Authority subscriptions to stay abreast of current regulatory changes.

Areas Covered in the Webinar:

  • Precedent, what is it?
  • Monitoring the regulatory landscape
  • Locating and analyzing precedent
  • Due Diligence
  • The Consultation Process
  • Partnering with groups outside of regulatory
  • Case Studies in Regulatory Intelligence
  • RI – a look to the future

Who Will Benefit:

  • Regulatory Specialist
  • Regulatory Managers
  • Marketing
  • Product Managers

Free Materials:

  • FDA Databases
    • 510(k) database
    • De Novo Device Classification Database
    • PMA Database
    • MAUDE Database
  • European
    • EUDAMED
  • Canada
    • MDALL
    • Medical Device Establishment License (MDEL) database
    • Medical Device License (MDL) Database
  • Japan
    • Review Reports – Devices
  • Australia
    • ARTG
  • Journals
    • FDA News
    • Medical Device Daily
  • Industry Organizations
    • AdvaMed
    • RAPS
    • WHO
    • WTO
  • Reference documents
  • Rule documents or guidance
  • Checklist
  • SOP template
  • Easy fill in forms
  • Articles
Instructor Profile:
James W Monroe

James W Monroe
President and CEO, Global RQC Med Device Solutions

Over the past 20 years James has been exclusively involved in the medical device field focusing on Regulatory Affairs and Quality Assurance. Within this arena he has focused on getting medical devices registered globally. His background and track record demonstrates his leadership, from product concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the Regulatory Bodies, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector through regulatory intelligence.

His regulatory focus is to develop and execute regulatory strategies for client domestically and internationally. He has successful gain multiple 510(k) clearances in the US, and approvals in the EU, Canada, South Korea, and Japan. He is at the forefront of regulatory intelligence staying abreast of the ever-changing medical device requirements globally. His device specialties include but are not limited to: Electro-mechanical and software driven devices, in-vitro diagnostics, digital health (Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity), and Risk Management.

He also holds both a Bachelors and Masters of Electrical Engineering. His Post-Graduate studies were conducted in the Department of Radiology at The Ohio State University where he developed hardware and software applications for the MRI systems and accessories. He has published multiple peer reviewed papers on image processing of medical images for image improvement.

He has held several leadership positions within regulatory and quality including: Director of Regulatory and Clinical at Pharmatech Associates-Medical Devices, Director Regulatory, Pentax Medical, Director of Regulatory & Quality at Immacor Inc., Interim Director at Convatec Inc., Manager of Regulatory at B. Braun Medical. In his role as a consultant he has worked globally with clients as the key regulatory expert responsible for developing regulatory strategies and gaining approval/clearance in multiple countries. He has also served as a 3rd party reviewer for the FDA’s 510(k) program at Intertek.

He has received clearance of over 35 510(k)”s, o f which 90%, involved software. More recently he has focused his regulatory experience in the area of digital health that includes: Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity, and Risk Management. He has also served as a 3rd party reviewer for the FDA’s 510(k) program.

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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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