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

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Please contact us concerning further inquiries.

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Contact

Stephanie Rex
Veranstaltungsorganisation

T: +43 (0)5 0454-8129
E: stephanie.rex@tuv.at

Facts

Presence course

Training units: 8

Course fee: see course details - On request. Please note that this training course is offered as inhouse training.

Requirements: Basic knowledge Quality Management: completed training course Quality Manager or three years working experience as Quality Manager or Director Quality Management (ISO 9001, EN ISO 13485, GMP)

Certification: Certificate of participation

Inhouse Trainings

Are you interested in training courses directly in your company?
More information can be found here.