ISO 13485: 2016 Medical Device QMS Requirements

This module is designed to introduce participants with the knowledge on classification of medical devices which are Class A, B, C and D. The process includes the classification of medical device and classification rules for medical devices. Participant will learn on the requirements of classificati...

Benefits of completing iso 13485 medical devices qms lead auditor course successful completion of this irca certified training course by passing the relevant irca examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management system audit.

Mastering Process Validation for Medical Devices: ISO 13485 & Regulatory Requirements Training. Empower your team with the knowledge and skills needed to ensure the reliability and effectiveness of your medical device manufacturing processes through our Process Validation Training.

Internal audit is a mandatory requirement of ISO 13485 2016 as it mandates the review and evaluation of the organisation’s quality management system QMS to evaluate its conformity with the ISO 13485 stipulated requirements, compliance with applicable regulatory requirements and whether the proced...

Medical device quality management system (mdqms) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labelling, and more. Most medical devices will r...