Management Systems for Medical Devices, the training provides a solid foundation and understanding of the laws, regulations, and standards that apply within the medical device industry. Furthermore, you will enhance your understanding of how management systems based on ISO 13485 can make companies successful and create sustainability in their processes.
The training provides a solid foundation and understanding of the laws, regulations, and standards applicable in the medical device industry. Furthermore, you will enhance your understanding of how management systems based on ISO 13485 can make companies successful and create sustainability in their processes. ISO 13485 is used to meet the regulatory and legal requirements necessary to provide medical devices and related services in Europe.
By implementing a quality management system in accordance with the standard, the applicable parts of the MDR (REGULATION (EU) 2017/745) and IVDR (REGULATION (EU) 2017/746) are fulfilled.
The course is aimed at quality managers/coordinators, management representatives, business developers, and anyone looking to implement a well-adapted, company-specific management system.
To benefit from this course, it is recommended that you have knowledge of the requirements in one of the following standards: ISO 9001, ISO 14001, or ISO 45001.
Course length: 1.5 days
Distance learning price: 9750 SEK per participant, excl. VAT. Documentation is included in the price.
Karolina Lindqvist: karolina.lindqvist@svenskcertifiering.se or 070 723 38 70
Svensk Certifiering Norden AB is accredited by SWEDAC to perform audits and certifications of management systems according to ISO 9001, ISO 14001, ISO 45001, ISO 27001, and ISO 13485.
Svensk Certifiering Norden AB is accredited by SWEDAC for personnel certification according to the specification Authorized Fire Alarm Engineer SBF 1007:5.
