Quality Management for Medical Devices
Quality Management Standards EN ISO 13485 and ISO TR 14969
Quality Management Systems (QMS) constitute to the production of medical devices, but are also very important in services like commerce or outsourced (sub-)productions. Admission requirements for medical devices use the guidelines of the EN ISO 13485 standard and this seminar focuses on the specific aspects for medical products.
Topics:
- Special requirements of EN ISO 13485
- Requirements concerning implants & steril devices
- Validation of processes (GAMP)
- QM standard requirements
- QM & risk management
- Software-Lifecycle-Management EN 62304
- Requirements for Canada (CMDCAS)
- Practical examples & workshop
Target group
Individuals in charge of construction, implementation and application of Quality Management Systems for medical device
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