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TSY In House Training #224: ISO 13485:2016 Understanding Requirements And Applications Training

TSY In House Training #224: ISO 13485:2016 Understanding Requirements And Applications Training
Training Ongoing.

This 2-day intensive in-house course provides key messages that are needed to obtain value from your organisation’s implementation of ISO 13485:2016 in compliance with applicable regional regulatory requirements. Either directly or indirectly, ISO 13485:2016 will have profound effect on the medical devices industry in this decade. In today’s medical supplies industry, the criteria of safe and effective medical devices are the key factors towards the consistency a quality management system in meeting the customer expectations as the basis for setting of strategy and objectives, the improvement of processes worldwide, and the measurement and overall improvement in strategic areas are essential to an organisation’s survival and in compliance with statutory and legal requirements.

The "hands-on" program includes lectures, workshops and a case study to increase participant knowledge and learning. This course is also available for in-house presentation with or without the ISO 13485:2016 standard. This training course may be used in its original presentation format or it may be customised by referring to the degree of business nature.

Date: 1st & 2nd December 2021

Venue: Polytool Technologies Sdn. Bhd., Bayan Lepas, Penang

Course Objectives:

This course provides delegates who intend to implement and maintain ISO 13485:2016 with effective implementation of key processes, throughout the organisation, and to contribute to the continual improvement of the management system. Here are the learning objectives for the two days training program; after completing this program, participants will be able to:

  • Understand the details of the ISO 13485:2016 risk-based requirements and applications for medical devices industry.

  • Identify the gaps and mapping out the key processes, applying suitable techniques and practical approaches in maintaining the ISO 13485:2016 risk-based requirements.

  • Detailing the Customer-Oriented, Management-Oriented and Support-Oriented Processes, including Risk Management based on ISO 14971:2019

  • Document the key business processes and identify the criteria needed to manage the processes effectively.

  • Develop a business management system control plan which will emphasise on stakeholders interests.

Who Should Attend:

Quality Managers, RA Managers, Auditors of Medical Device, Executives & Senior Management, Cross functional team members of implementation project, Suppliers to the organisation.

More Training Pictures:

Feel free to contact TSY Consultancy by Call / WhatsApp to +6012-6243921 or email to


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