ISO 13485:2016 - Introduction and Implementation
This course is certified by Exemplar Global.
- Based on ISO 13485:2016 you will know how to introduce respectively to optimize a quality management system in your company.
- You benefit from the detailed standard interpretation of ISO 13485:2016 by our experts.
- Medical device manufacturer and supplier’s personnel who will be involved in the launch of management systems or updating of the current management system
- Quality management officers (QMOs), product managers, regulatory affairs managers
- Consultants in the medical device industry
- Introduction to the legal and normative environment of ISO 13485:2016
- Legal environment (national and international) and regulatory framework
- Lifecycle of a medical device
- Classification of ISO 13485:2016
- ISO 13485:2016 in detail
- Process validation and risk analysis, documentation
- Qualification and infrastructure
- Development (design control, clinical data, validation)
- Supplier management
- Production control
- Continuous improvement process (CIP): internal errors, complaints, risks
- Corrective and Preventive Actions (CAPA), reporting process
- Workshop: deepen the knowledge about the chapters of ISO 13485:2016
The international standard ISO 13485:2016 forms the basis for an effective quality management system in the medical device industry and its suppliers. We recommend you join this seminar if you would like to familiarize yourself with the contents of ISO 13485:2016 and options for its practical implementation.
What are the requirements for the quality management systems of medical device manufacturers? At the heart of ISO 13485:2016 is a comprehensive process risk management to be integrated in all medical device-related quality management processes of the company, including outsourced supplier processes. Beside development and production of a medical device, processes have to be taken into account after the medical device have been placed on the market.
Our two-day seminar will provide you with basic theoretical knowledge regarding ISO 13485:2016 and the implementation workshop, will explain in detail how to integrate practically the requirements for a quality management system into your company's processes.
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.Learn more about TÜV SÜD's Exemplar Global Accreditation today
This online instructor-led seminar addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion