When you bring medical devices into the European internal market (EU), they must comply with European quality legislation and guidelines. Implementing a quality system according to ISO 13485 and ISO 14971 will help you with this. The practical training Quality and Risk Management of Medical Devices according to ISO 13485 and ISO 14971 guides you through the background, integral content and requirements for complying with these standards.
- ISO 13485: Learn all the essential components in quality control and its application
- ISO 14971: Know the background, content and integral application of risk management in business operations
- Know what requirements the quality system must meet
About the training course Quality and risk management of medical devices according to ISO 13485 and ISO 14971
At the end of this training you will know:
- ISO 13485: All the essential elements in quality management and its application
- ISO 14971: the background, content and integral application of risk management in business operations
- The relationship between the two standards and with the European laws and regulations for medical devices
Programma
- The Background and Basic Principles
- The history of this standardization and its relationship with EU and US regulations
- The requirements that the quality system must meet
- General Quality System Requirements
- Director's responsibility
- Resource management
- Product realisation
- Measurements, analyses, improvements
- The essence of risk management according to ISO 14971
- The possibilities of the combined application of the ISO standards
- The main similarities and differences between ISO 14971:2019, ISO 14971:2012 and ISO 14971:2007
Place, dates and prices - Open registrations
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Mikrocentrum uses all-inclusive rates. All mentioned rates are exclusive of VAT and include course materials and package costs.
Members of the Mikrocentrum High Tech Platform get a 10% discount.
Discover the possibilities to organize this course incompany
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination with your company-specific situation and the deployment of highly experienced lecturers who have earned their spurs in practice is essential here. Mikrocentrum is CEDEO-recognized and guarantees the best quality.
Our training manager is happy to think along with you!
Are you interested in an incompany process? Our training manager Barend Blom will be happy to visit you without obligation.