ISO 13485:2016 Medical Devices Awareness
ISO 13485:2016 Medical Device Quality Management System Awareness Training provides a foundational introduction to the internationally recognized standards that govern the quality management systems specific to the medical devices industry. This training focuses on the importance of aligning organizational processes with best practices outlined in ISO 13485:2016 to ensure safety, compliance, and efficiency in the medical device sector.
The program is delivered using a combination of instructor-led lectures, case study and exercises on practical implementation of the concepts discussed within the training. The topics presented below define the areas of focus under the program.
Benefits
Target group
This training is designed for individuals and teams involved in any stage of the medical device lifecycle, including:
- New Employees in the Medical Device Industry
- Quality Assurance Personnel
- Regulatory Affairs Managers
- R&D Professionals
- Supply Chain Managers
Requirements
To fully benefit from this training, participants should have:
- A foundational understanding of ISO 9001:2015 Quality Management Systems.
- Some experience auditing practices is recommended but not mandatory.
No advanced technical skills are required, making this training accessible to anyone looking to enhance their auditing capabilities within the ISO 13485:2016 environment.
Training outline
Other information
For payment and other inquiries, please contact Ms. Ma.Luisa Anne Francisco, Senior Sales Executive (MaLuisa.Francisco@tuv.com | +63 998-840-7850).
Additional Details
- The fees cover training materials and a certificate.
- A 12% VAT is included in the training fees.
Cancellation and Postponement Policy
- TÜV Rheinland Philippines, Inc. holds the authority to delay or cancel public courses. The following points provide further detail:
- Unless a course is cancelled by TÜV Rheinland Philippines, training fees are non-refundable.
- Cancellations made five days or fewer before the scheduled training will not be eligible for a refund. The full training fee will be charged and invoiced.
Delegate Substitution
- If you are unable to attend the training, you may nominate a substitute delegate to attend in your place. Please ensure to inform us of the substitute delegate’s name and title.
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