Certified Medical Device Professional (CMDP) Training Course

Certified Medical Devices Professional Training

What is CMDP?

CMDP (Certified Medical Device Professional) is an integrated personal certification programme for Medical Device Professionals focusing on providing indepth implementation knowledge on product certification for CE marking. In this program we will facilitate you develop your skills and understanding of the practicalities involved while preparing the Technical File that conforms to the requirements of Medical Device Directives. This includes introduction on Clinical Evaluation, Risk Management, harmonised standards applicable for Medical Device Directive (93/42/EEC) & In-vitro Diagnostic Device Directive (98/79/EEC) and effective submission of Technical File for CE Marking the Medical Devices and IVDs.

Why CMDP Personal Certification?

  • A modular step by step program to build your credentials in technical and regulatory areas of focus in the medical device industry
  • Gain  an edge over competition with this personal certification program and stand out in this fast growing sector
  • Learn the latest developments that impact the regulatory environment for medical device registrations in key markets

At the end of the course, participants write an exam and successful clearance earns them CMDP certification.


Who should become Certified Medical Device Professional?

  • Regulatory, quality, design, development, manufacturing, marketing managers and personnel
  • Organizations designing/manufacturing/distributing Medical Devices & IVDs
  • Organizations preparing “own branding” or “private labeling” of Medical devices & IVDs
  • Potential internal auditors and others who need an in-depth knowledge of the requirements of the medical devices & IVD directives

What will you learn?

Upon completion of this training, delegates will be able to:

  • Explain the European CE marking approach
  • Explain the structure and purpose of the medical devices directive and IVD directive
  • Implement the EU risk classification criteria for medical devices & IVDs
  • Identify the conformity assessment routes and quality assurance requirements for the various risk classes
  • Identify the product specific harmonized standards applicable for Medical Devices and IVDs
  • Identify the Safety Test requirements
  • Describe the role of the essential requirements as the basis for CE Marking
  • Identify the requirement of clinical data
  • List the labeling requirements
  • Identify the regulatory significance of risk management and process validation
  • Identify the necessary steps required for post market surveillance for different risk classes
  • Interpret the criteria for reporting adverse incidents under the vigilance system
  • Define the manufacture’s regulatory responsibilities, including reporting of changes to products and QMS system to the notified Body
  • Identify the relevance of recent changes to the medical devices & IVD directives
  • Conduct internal and external audits for compliance with the directives 4

What each course module offers?

  • The three-day medical device CE marking module provides in depth knowledge on the regulatory framework that governs CE marking of medical devices covered under the Medical Device Directive (93/42/EEC) {Includes details on device classification and selecting the appropriate conformity route}
  • The one-day in-vitro diagnostic device CE marking module provides in depth knowledge on the regulatory framework that governs the CE marking of in vitro diagnostic devices covered under the in-vitro diagnostic device directive (98/79/EC) { Includes details on device classification and selecting the appropriate conformity route}
  • The one-day module on risk management provides a thorough outline to develop and build the risk management process within an organization in line with the requirements of the EN ISO 14971
  • The one-day module on clinical evaluation of medical devices provides in depth knowledge on how to prepare a clinical evaluation summary that meets the requirements of the EC directives for CE marking

How will your organization benefit?

  • An understanding of Medical Device Certification for CE
    Marking
  • Have the capability to Improve the effectiveness and efficiency of the Product Certification processes
  • Be confident that you will be able to play pivotal
  • Role in third party and customer audits
  • Can be utilized as qualified internal auditor

What will include in program?

  • Refreshments & Lunch
  • Course Folder, Pen & Notepad
  • CMDP Certificate of attending/passing the examination
  • CMDP Directory of trained professional will be maintained on BSI's website
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