Description

Quality Systems and Internal Audit for Medical Device Testing Laboratories as per ISO/IEC 17025:2017

Master the Convergence of Laboratory Competence and Medical Device Regulatory Excellence

 

In the critical field of medical device testing, patient safety and regulatory compliance hinge on data that is not only technically sound but also generated within a rigorously controlled quality system. The ISO/IEC 17025:2017 standard is the essential benchmark for competence in testing laboratories, and its application in the medical device sector requires specific expertise. This comprehensive course is your definitive guide to understanding, implementing, and auditing a management system that meets both ISO/IEC 17025:2017 and the stringent expectations of global medical device regulations (like MDR, IVDR, FDA QSR). By focusing on the unique risks and requirements of the sector, you will gain the knowledge to ensure your laboratory's reliability, support regulatory submissions, and play a pivotal role in bringing safe devices to market.

 

What You Will Learn

By the end of this course, you will be able to:

  • Interpret ISO/IEC 17025:2017 with a specific focus on its application in the medical device testing environment.

  • Integrate Regulatory Requirements from standards like ISO 13485 and regulations (e.g., EU MDR/IVDR) into your laboratory's quality management system.

  • Develop & Implement a Compliant QMS tailored for medical device testing, covering critical aspects from method validation and equipment control to personnel competence and sample handling.

  • Plan and Conduct Effective Internal Audits specifically designed to assess compliance with both ISO/IEC 17025 and applicable medical device regulatory requirements.

  • Manage Critical Processes such as handling of confidential device information, design control testing, biocompatibility, and sterilization validation testing within the lab.

  • Apply Knowledge Practically through sector-specific case studies and workshops on auditing test methods, reporting results for regulatory submission, and managing audit trails.

 

Course Curriculum

The course is structured into digestible modules, designed for optimal learning flow:

  • Module 1: Introduction: The Crucial Role of Labs in the Medical Device Ecosystem and Regulatory Landscape

  • Module 2: ISO/IEC 17025:2017 Deep Dive – Key Clauses and Sector-Specific Interpretations for Device Testing

  • Module 3: Integrating Medical Device Requirements: Risk Management, Design Control, and Regulatory Interaction

  • Module 4: Conducting Effective Internal Audits in a Medical Device Laboratory – Protocols, Checklists, and Non-Conformance Management

  • Module 5: Case Studies & Workshops: Auditing High-Risk Areas (Biocompatibility, Sterility, Software Validation) and Interactive Q&A

 

Who Is This Course For?

This course is essential for professionals involved in the quality and technical management of laboratories serving the medical device industry, including:

  • Quality Managers, Technical Managers, and Laboratory Directors in medical device test labs

  • Regulatory Affairs and Compliance Professionals dealing with laboratory data

  • Internal Auditors and Aspiring Assessors for medical device or testing lab accreditation

  • R&D and Product Development Engineers who rely on laboratory data

  • Consultants and Quality Professionals supporting the medical device sector

 

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a basic understanding of ISO/IEC 17025:2017 concepts and general familiarity with medical device industry operations or quality systems (e.g., ISO 13485) to maximize their learning.

 

Course Features & Included Materials

  • Interactive Learning: Engage in hands-on exercises and scenario-based workshops tailored to medical device testing challenges.

  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced assessors familiar with both accreditation and medical device regulations.

  • Comprehensive Learning Materials: Digital Learning Materials and a copy of ISO/IEC 17025:2017 (For Training Purposes only).

  • Certificate of Training: Earn a verifiable, with a unique ID and QR code, soft-copy certificate, shareable on professional networks like LinkedIn.

 

Enroll Today and Become a Linchpin for Medical Device Quality and Safety!

Invest in your skills to bridge the gap between laboratory science and regulatory compliance. Gain the confidence to implement and audit a management system that ensures trust in every critical test result.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org or call +91 97735 00376.