ISO 13485:2016 Medical Device Management Systems Awareness

By enrolling for the ISO 13485 awareness training course, participants will:

• Understand the structure, requirements, and scope of the ISO 13485:2016 standard
• Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
• Recognise the value of ISO 13485 certification and how it contributes to medical device quality and regulatory compliance
• Learn about quality management principles and their use in the medical devices sector
• Learn practical methods for risk management, process validation, and documentation in the context of ISO 13485
• Understand the basics of maintaining product quality and safety, navigating supplier management, traceability, and post-market surveillance for medical devices
• Stay informed on the most recent innovations, and regulatory changes affecting the medical devices sector

The topics covered in this course are as follows:

• An introduction to Quality Management Systems for medical devices
• A comprehensive review of ISO 13485:2016 requisites
• Detailed comparisons of ISO 13485:2016 against ISO 13485:2003 requirements

The ISO 13485 awareness course is specially designed for:

• Medical Device Manufacturers
• Quality and Regulatory Professionals in medical device manufacturing
• Management Representatives and Consultants
• Founders/CEOs of medical device companies
• Product Developers/product designers, engineers and testing personnel
• Quality Managers and Quality Associates in medical device manufacturing
• Personnel, Contractors, Subcontractors
• Material Suppliers
• Medical Device Service Providers, including maintenance workers/validation teams
• Purchasing teams and Operational team members
• Medical device software designers and software update support personnel
• QMS documentation specialists

There are no prerequisites recommended for this course. Candidates with experience with medical equipment and a passion for working in the medical field will find the course very beneficial.

Understanding ISO 13485:2016 will help you grasp the regulatory requirements and compliance obligations that medical device companies must meet. Many medical device companies require experts in regulatory affairs to navigate complex regulations. A certification or knowledge of ISO 13485:2016 can enhance your career prospects in the industry.

The course content and its structure have been meticulously crafted by TÜV SÜD's domain experts. Drawing upon their extensive experience and deep understanding of standards, our team of specialists and technical experts at TÜV SÜD have tailored the course content to align with the contemporary medical landscape and the market demands.

Upon successful completion of the ISO 13485 awareness certification course, you will receive a certificate of completion. This document attests that you have met the requirements and demonstrated competence in ISO 13485:2016 awareness. This certification adds credibility to your knowledge and skills, demonstrating to employers and clients that you have a solid understanding of ISO 13485:2016.

1. Can I take the ISO 13485:2016 Medical Device Management System Awareness instructor-led course in addition to doing e-learning courses?
Yes, you can register for any e-learning course at TÜV SÜD.

2. How do I enroll for the ISO 13485:2016 Medical Device Management System Awareness course?
To enroll, please click on "Buy now" and check out your cart.

3. What is the ISO 13485:2016 Medical Device Management System Awareness course methodology?
Participants will learn through role plays, case studies, group exercises, scenarios, and discussions.

4. Can I get a refund if I cancel my enrollment?

• If the cancellation is communicated to us by email within 14 days before the confirmed training date, no refund will be provided for the training.
• If the cancellation is communicated to us by email more than 14 days before the confirmed training date, a refund of 50% of the total fee paid will be issued.

Note: In-house trainings are not applicable for manufacturers in medical device & healthcare industries.