Classifying Medical Devices - US and EU - Online Webinar

Tuesday, Mar 21, 2017 at 10:00AM - 1:00PM

Event Details

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.

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.

Objectives of the Presentation
At the completion of this training participants will be able to:
  • Explain the importance of properly classifying medical devices
  • Compare and contrast the similarities and differences globally in medical device classification processes
  • Explain how to determine if your product is a medical device
  • Explain the purpose and function of the medical device classification panels?
  • Identify and explain Medical Device exemptions and state when they apply
  • Explain the purpose of the product code classification database and explain how is it used?
  • Explain the process of classifying medical devices in the EU in terms of the new Medical Device Regulation
Why Should you Attend
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
  • 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 will Benefit
This webinar is applicable to the Medical Device industry
  • Audit and Compliance Personnel
  • Regulatory Professionals
  • Quality Professionals
  • Risk Managers
  • Design Engineers
  • Research and Development Engineers
  • VP, Directors and Managers of medical device design functions & Medical device marketing and sales personnel.

For Registration

Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont 94536

Starts March 21, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896