Training Features

Change Management in the Medical Device Industry

Master the art of Change Management in the Medical Device industry. Remain Compliant, Efficient, and Audit Ready.
Format

E-Learning

Level

Advanced

Trainer

Swaroop Nair

Exam

Exam and certificate included

Duration

1 hour and 30 min.
14 modules

Price

€ 275 or equivalent currency

Change Management in the Medical Device Industry

This e learning course explains how to manage changes effectively within a regulated medical device environment, while maintaining compliance with MDR, IVDR, and quality system requirements. You will learn how to assess, document, and implement changes in a structured way that supports patient safety, business continuity, and regulatory expectations.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
These learning objectives are designed to provide participants with an in-depth understanding of the change management process within the medical device industry, including both regulatory and quality system requirements under frameworks such as ISO 13485, FDA regulations, and the EU MDR.  

When this training is completed, participants will have gone through the following learning objectives:
  • Understand the principles and regulatory expectations of change management in the medical device industry, including ISO 13485, FDA and EU MDR requirements.
  • Identify and differentiate types of changes and classify them appropriately e.g. as minor/major or significant/non-significant.
  • Recognize common interfaces and triggers for change.
  • Apply a structured change control process, including initiation, impact assessment, review, approval, implementation, verification and closure.
  • Document and trace changes effectively, ensuring control of impacted documents, design files and technical documentation.
  • Avoid common pitfalls and inspection findings by aligning with best practices and maintaining audit-ready reports.
  • Utilize tools, forms and templates to manage in a scalable and compliant manner, appropriate for start-up and growth-stage companies.
We expect participants in this training to have some basic knowledge of the following: 
  • Quality management system basics for medical device & IVD manufacturers based on ISO 13485 such as principles of design control, document control, and change control. This is covered in our training on ISO 13485 principles for medical device & IVD manufacturers.
  • FDA, 21 CFR Part 820 Quality System Regulation.
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. xxxxxxx
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
The target group for this training are professionals working for medical device manufacturers, or suppliers, subcontractors, and other economic operators in the medical device industry, involved in initiating, assessing, approving, implementing, or overseeing changes within their organizations. 

Typical functions include:
  • Quality Assurance (QA) personnel/ Quality Engineer/ Quality Manager 
  • Regulatory Affairs (RA) specialist or Manager 
  • R&D Engineers  
  • Manufacturing & Process Engineers 
  • Validation specialist 
  • Document control specialists 
  • Project Managers/ R&D Leads 
  • Executive & Management Team.

Comprehensive Regulatory Expertise

Gain recognized certification, advance your regulatory career, and learn at your own pace with a flexible learning schedule designed for medical device professionals.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

Swaroop Nair

Swaroop is a Consultant in Medical Devices Quality and Regulatory Affairs at Qserve, holding an MSc in Biomedical Engineering from FH Aachen and nearly five years of experience focused on ensuring the safety, reliability, and regulatory compliance of innovative medical technologies.