Understand, interpret and implement requirements of EN ISO 13485:2016 for the medical device industry.
The EN ISO 13485 is the basis for QM systems in the medical device industry. EN ISO 13485:2016 defines new requirements for medical device manufacturers and specifies the requirements of the predecessor standard. Get to know the structure and contents of EN ISO 13485:2016 and learn how to set up or adapt your QM system accordingly.
Nutzen
You will learn about the structure, contents and requirements of EN ISO 13485:2016/AC:2016 as well as the main differences to the previous version EN ISO 13485:2012+AC:2012.
You know how to introduce a QM system based on EN ISO 13485: 2016/AC:2016 or how to adapt your own quality management system to the new requirements.
You benefit from concrete practical examples that make it easier for you to implement or adapt your system.
Abschluss
Teilnahmebescheinigung
certificate of attendance
Zielgruppe
The seminar is suitable for employees who are or will be responsible for the implementation of EN ISO 13485 in medical device companies.
Inhalte
Structure, (new) requirements of EN ISO 13485:2016/AC:2016
EN ISO 13485:2016/AC:2016 and the specific national, regional or international regulatory requirements for medical device manufacturers
Integration of risk management in the QM system or in the company processes including outsourced processes and the entire product life cycle
Selection and ongoing evaluation of suppliers
Documentation structure and evidence documents
Validation, verification, design transfer
dealing with complaints
Feedback and reporting
Major differences to EN ISO 13485:2012+AC:2012
Audits and inspections according to EN ISO 13485:2016/AC:2016 by the notified body or competent authorities - EN ISO 13485:2016/AC:2016 versus MDR (Medical Device Regulation)
ISO 13485 as the basis for the global Medical Device Single Audit Program (MDSAP)
Tipps for implementing EN ISO 13485:2016/AC:2016 in your company
Hinweise
The seminar contents take into account the current status of regulations/harmonization
