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Medical Device Classification - US and the EU as per MDD, CMDR and GHTF

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The Medical Device Classification webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk based approach implemented by regulatory authorities.

Speaker
Instructor: Daniel O Leary
Product ID: 701539
Training Level: Intermediate to Advanced

Why Should You Attend:
In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional system the FDA employs, classifying each device by risk class and associated panel. This leads to specific regulations for each device type.

The EU’s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, and III). The risk class of the device determines the available conformity paths the manufacturer may use to affix the CE mark. This webinar explains the risk classification and conformity paths using the MDD version in effect after March 2010. (Note that the classification schemes in the IVDD and AIMDD are the same as the MDD, and are not included in the webinar.)

The Canadian Medical Device Regulations (CMDR) classifies devices into four risk categories (I, II, III, and IV). Classification follows a rule based system set forth in Schedule 1 of the CMDR.

The Global Harmonization Task Force (GHTF) has a guidance document on medical device risk classification that uses four classes (A, B, C, and D) based on risk level. This is a rule based system defined in the guidance document.

Learning objectives:

Areas Covered in the seminar:

Who will benefit:

This seminar is designed for people involved in the classification, design, development production, and marketing of medical devices. Teams are especially encouraged to attend to help clarify the concepts of device classification. This will also help understanding of global marketing, design inputs and their role, and paths for conformity assessment.People in the following roles can especially benefit from the knowledge in this webinar:

Instructor Profile:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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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 only 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."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 75 Min
$249.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
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