ISO 13485 for Medical Devices? What are the requirements for ISO 13485:2016? All clauses in Hindi

ISO 13485 for Medical Devices? What are the requirements for ISO 13485:2016?
All clauses in Hindi

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ISO 13485:2016 Medical devices quality management systems - Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

👉 Topic information below:
00:30 : Introduction
01:34 : Benefits of ISO 13485
03:57 : Clause No. 1 - Scope
04:50 : Clause No. 2 - Normative references
05:02 : Clause No. 3 - Terms and definitions
05:15 : Clause No. 4 - Quality management system
09:46 : Clause No. 5 - Management responsibility
14:30 : Clause No. 6 - Resource management
17:00 : Clause No. 7 - Product realization
28:22 : Clause No. 8 - Measurement, analysis and improvement
34:50 : Outro


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Thanks for watching.
Neeraj Bargoti

[jobinajahan]

Sir gud explained, but background video was not required.

[KWafa-bi]

You should understand to viewer in written form plz