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Quality is always the result of excellent work without compromise.​

MMD-104    EU Medical Device Clinical Evaluation

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
<
>
A clinical evaluation needs to be conducted on each medical device type or family by the manufacturer in order to allow the medical device to be legally placed in certain regulated markets. This is a mandatory prerequisite regardless of the risk classification. The collation of clinical data is a key aspect of the EU CE Marking conformity assessment process. It allows the manufacturer to substantiate safety, performance and benefit/risk assessment claims made.
 
Revision 4 of the MEDDEV guidance document 2.7/1 was released on 1st July 2016. This new version includes new requirements and is aligned with the EU Medical Device Regulations and also covers requirements specifically for Post-Market Surveillance (PMS), and Post-Market Clinical Follow-Up (PMCF).
 
Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor and technical file reviewer, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience. Participants will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance.
  • Determine whether or not a clinical investigation is required for their device
  • Prepare a clinical evaluation in accordance with MED DEV 2.7.1 and GHTF Guidance Documents
  • Implement risk evaluation pre/post review
  • Establish design and intended use equivalence with competitor and pre existing designs
  • Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements
  • Identify residual clinical risks and determine whether post-market clinical follow-up is required
  • Maintain and update clinical evaluation documentation throughout post-market product lifecycle
  • Considerations in determining as to whether clinical trials/ investigation are required for a particular medical device
  • Clinical Evaluation requirements as specified in MEDDEV 2.7/1 rev.4
  • GHTF/IMDRF guidance on Clinical Evaluation
  • Pre and Post Review Risk Evaluation
  • Aspects of design and intended use equivalence
  • Clinical Literature reviews
  • Notified Body expectations on Clinical Evaluation documentation submissions
  • Clinical data in meeting the General Principles of Safety & Performance
  • Post Market Clinical Follow-ups and residual clinical risks
Those whom contribute towards ensuring the medical device meet regulatory requirements for risk management as well as those whom conduct change management, including:
  • Management representatives
  • Those involved in contributing information towards as well as collating information for establishment of technical documentation
  • QA and Regulatory Personnel
  • Internal Auditors
This is a 1-day programme.
​

This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
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We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.

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©  Ampro Solutions Sdn Bhd 2023
  • Home
    • About Us
    • Authorized Training Partner
  • Our Services
    • On-Site Training
    • Off-Site Training
    • Coaching
    • Audit Support
    • Consultation Services >
      • Energy Management >
        • Remote Power Management Services
      • Management Systems >
        • ISO 50001 Energy Management System
        • ISO 9001 Quality Management System​
        • ISO 14001 Environmental Management System
        • ISO 45001 Occupational Health and Safety Management System
        • IATF 16949 International Automotive Task Force
        • ISO/IEC 17025 Testing and Calibration Laboratories
        • ISO 13485 Quality Management for Medical Devices
        • AS 9100 Quality Management System for Aerospace Industry
        • ISO 20000 IT Service Management
        • ISO 22301 Business Continuity Management
        • ISO 31000 Risk Management
        • ISO 37001 Anti-Bribery Management System
        • ISO 55000 Asset Management
        • TL 9000 The Telecom Quality Management System
        • Food Safety Management System
        • Integrated Management System (IMS)
      • The Malaysian Standard for Sustainable Palm Oil Production (MSPO) >
        • General Differences between MSPO and RSPO
        • Deadlines for MSPO Certification
        • MSPO Certification Process
        • Photo Gallery
      • Business Continuity Management >
        • How We Can Assist You
      • Halal Certification >
        • Certification Scheme
      • Safety and Health Officer Support
  • Training Courses
    • Soft Skills >
      • Leadership & Supervision Skills
      • Motivation & Teambuilding
      • Communication & Interpersonal Skills
      • Presentation & Public Speaking Skills
      • Clerical & Administrative Skills
      • Customer Relationship Management Skills
      • Negotiation Skills
      • Sales & Marketing
      • Creative Thinking & Problem Solving
      • Human Resource
      • Microsoft Office
    • Business Management >
      • Purchasing & Logistic
      • Supply Chain Management
      • Process Improvement & Core Tools
      • Responsible Business Alliance (RBA) and Sedex Members Ethical Trade Audit (SMETA)
      • Lean & Six Sigma
      • Electrical & Electronics
      • Project Management
      • Industry 4.0
    • Manufacturing Operations >
      • ISO 50001 Energy Management System / Energy System
      • ISO 9001 Quality Management System
      • ISO 14001 Environmental Management System
      • ISO 45001 Occupational Health and Safety Management System
      • ​IATF 16949:2016 International Automotive Task Force
      • ISO/IEC 17025 Testing and Calibration Laboratories
      • ISO 13485 Quality Management System for Medical Devices
      • AS 9100 Quality Management System for Aerospace Industry
      • ISO 22000 IT Service Management
      • ISO 22301 Business Continuity Management
      • ​ISO 31000 Risk Management
      • ​ISO 37001 Anti-Bribery Management System
      • ​ISO 55000 Asset Management
      • Food Safety Management System
      • TL 9000 Telecom Quality Management System
      • Integrated Management System
    • Health & Safety >
      • Occupational Health & Safety
      • First Aid
      • Fire Safety
      • Transportation Safety
    • Malaysian Standard for Sustainable Palm Oil Production (MSPO)
  • Events
    • Remote Online Training
    • Public Training in Johor Bahru
    • Public Training in Kuala Lumpur
    • Online Registration
  • External Info
    • Human Resource
    • Environment
    • Health & Safety
  • Contact Us
    • Career Opportunities