Establish an efficient quality management system for medical devices with ISO 13485
Considered as one of the most highly regulated sector in the world, the medical devices industry must demonstrate compliance with regulatory and product requirements to ensure safety and performance of medical devices produced.
ISO 13485:2016 Medical Device Management Systems (MDMS) is the international standard that sets out the requirements for Quality Management System standard specifically for the medical devices industry. It encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements. It is designed to be used by organisations throughout the lifecycle of a medical device and it also covers storage, distribution, installation and servicing, and the provision of associated services.
The MDMS courses will provide the knowledge and understanding of the requirements of ISO 13485:2016 to help organisations increase their competitive advantage in the medical device industry.
At the end of the course, participants will be able to:
• Understand the requirements of ISO 13485:2016 for medical products and related services
• Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
• Acquire the skills to take on the position of an internal medical services auditor in the company
WHAT ARE THE MEDICAL DEVICE MANAGEMENT SYSTEMS COURSES AVAILABLE?
Available Medical Device Management Systems instructor-led courses include:
• ISO 13485:2016 Medical Device Management Systems Awareness
• ISO 13485:2016 Medical Device Management Systems Internal Auditor
• Medical Device Single Audit Program (MDSAP) Awareness
• Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective Training
• In Vitro Diagnostic Regulation Training
WHAT IS THE COURSE METHODOLOGY?
Participants will learn through lectures, case studies, group exercises and discussions.
The courses are specially designed for:
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
To know more about TÜV SÜD, please click here.
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Bosnia and Herzegovina