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ISO 13485 Awareness Training

Awareness Training Program Based on ISO 13485:2016 Standard (Medical Device)

WHAT IS ISO 13485:2016

ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system

YOUR BENEFITS

This programme will provide participants an insight of the ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes).

COURSE CONTENT / OUTLINE

  • Basic Introduction to ISO 13485: 2016
  • Relation ISO 9001:2015 / ISO 13485:2016
  • Key issues addressed by ISO 13485:2016
  • Integration of Risk Management ISO 14971 in ISO 13485

WHO SHOULD ATTEND?

  • Medical Device Manufacturers.
  • Quality Professionals
  • Regulatory Professionals
  • Internal and external Auditors
  • Consultants and anyone involved with the implementation of the standard

TRAINING DURATION

01 Days

PREREQUISITES

Preferred to have basic knowledge in Quality Management system and / or experience if medical device, Pharmaceutical operations.

PARTNER INSTITUTE INFO (IF ANY)

Nil

EXAM DETAILS (DURATION, PATTERN)

No Examination

CERTIFICATION

Certificate of participation

Next Steps

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