Skip to main content

Classifying Medical Devices in US and EU

Compliance Key INC - Healthcare Compliance Webinars
Overview
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.The determination process, how you apply the classification process to your device, is complex and requires several levels of analysis to make the proper device classification.
Proper medical device classification is the fundamental first step in submitting your device for approval anywhere in the world.
This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provide detailed background into the process and will make clear some of the very complex terms and sub-processes associated with medical device classification. We will actually work through the classification process step-by-step for the US and will overview how the process is accomplished for the EU.
Why should you attend this webinar?
When designing and developing medical devices it is essential to properly classify your device early on in the process to prevent costly and cumbersome regulatory issues and added or unnecessary work later in the design and development process.
What is the impact? What is the cost? Making the wrong decision ? assigning your device a higher classification than necessary within any market can cost you significant time and money in terms of your submittal process and how the design, development, and the management of your device will be executed over its lifecycle.
Areas Covered in the Session:
  • Purpose and reason for classifying medical devices
  • Medical device determination
  • The medical device classification panels
  • Medical Device exemptions and when they apply.
  • Product code classification database and how it is used
  • The process of classifying a medical device in the US
  • The process of classifying a medical device in the EU
  • The impact of the new EU Medical Device Regulation on EU medical device classifications
Who can Benefit:
Anyone involved in the design, development, marketing, submittal, and approval of medical devices that have had some exposure to the subject area and regulated environments.

Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

New 2019 HIPAA Guidance on De-Identifying Protected Health Information

Compliance Key  -   HIPAA Compliance Training Overview This seminar will be addressing how practice/business managers or compliance officers need to get their HIPAA house in order, as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major 2019 changes taking place with the Health and Human Services regarding the enforcement of the HIPAA law as well as detailed discussions on the Phase 2 audit process and current events regarding HIPAA cases (both in courtrooms and from real-life Audits). Our instructor - Mr. Brian Tuttle  has over 20 years of experience in working as Compliance auditor and has been an expert witness on multiple HIPAA cases. He`ll thoroughly explain on HOW and in WHAT scenarios patients can claim for cash remedies. More importantly, Brian will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Why should you attend this seminar? This Seminar will go over s
Post a Comment
Read more

SOX Compliance: Accounts Receivable Risks and Controls

Overview The accounts receivable process includes the sub-cycles of acquiring and accepting customer orders; writing sales contracts; granting customer credit; shipping or otherwise delivering products or services; billing and recording sales and lease transactions; maintaining and monitoring accounts receivable; instituting effective collection procedures; recording and controlling cash receipts; establishing pricing and promotional activities; and properly valuing receivable balances. In management's selection of procedures and techniques of control, the degree of control implemented is a matter of reasonable business judgment. The common guideline used in determining the degree of internal controls implementation is that the cost of a control should not exceed the benefit derived. The Order to Cash Process (O2C) Process is comprised of several sub-processes that must have a foundation of internal controls for SOX 404 certification process. This webinar wil
Post a Comment
Read more

How to Return Manufacturing to America Using Total Cost of Ownership Analysis?

How to Return Manufacturing to America Using Total Cost of Ownership Analysis? Michele Nash-Hoff Michele is founder and president of ElectroFab Sales, a sales agency specializing in helping manufacturers select the right processes for their products since 1985. She is currently a director on the board of the and the San Diego Inventors Forum and is also Chair of the California chapter of the Coalition for a Prosperous America. Michele is the author of Rebuild Manufacturing - the key to American Prosperity and Can American Manufacturing Be Saved? Why We Should and How We Can available at www.amazon.com. She has written regular articles for IndustryWeek?s e newsline, as well as many other e........ Read More Overview Moving manufacturing offshore led to the loss of 5.8 million manufacturing jobs and the loss of 60,000 companies and since the year 2000. What was the impact on the American economy? Is manufacturing returning to America? In this webinar, expert
Post a Comment
Read more