Total Product Life Cycle Development (TPLCD)

Instructor: James W Monroe
Product ID: 706460
Training Level: Intermediate
  • Duration: 60 Min
This webinar will discuss the multi-faceted aspects of bringing a medical device to market. The webinar explores topics ranging from market concept to post-market surveillance. Entering a medical device market involves more than engineering and regulatory compliance. Companies need to consider a variety of issues to successfully enter the medical device market.
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Read Frequently Asked Questions

Why Should You Attend:

This webinar will focus on those aspects of bringing a medical device to market that compliments the central design and development process. This includes market research (is there a market for my product), cost/benefit analysis, time to market analysis, regulatory/quality requirements, reimbursement strategies, investor strategies, product development.

The knowledge you gain in the webinar will help you discover answers to the following questions.

  • I have a product, is there a market for my product?
  • Funding: Do I need it, how do I go about it?
  • What is the cost to bring my product to market?
  • How long will it take to get my device to market?
  • What is my competition?
  • What are my regulatory obligations?
  • Will my product be reimbursed?
  • Am I subject to being audited?

Areas Covered in the Webinar:

  • Market Research
  • Investor Funding
  • Cost(s): Device Development
  • Regulatory Strategies
  • Regulatory Registration
  • Product Development
  • Commercialization
  • Quality Systems
  • Post-Market Surveillance

Who Will Benefit:

  • Inventors
  • Device Manufacturers
  • Investors
  • Regulatory Professional
  • Marketing Executives
  • Product Managers
  • Consultants

Free Materials:

  • Greenlight Guru: A Complete Guide to Bringing a Medical Device to Market
  • Medical Device Design: Innovation from Concept to Market, Peter Ogrodnik
  • US FDA 21 CFR 820 Design Controls
  • EU MDR 2017/745 Medical Device Regulation
  • FDA QSR/ISO 13485:2016 Quality System Requirements
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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Managing Your Complaints and Obstacles in Post-Market Requirements

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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