Standard Technical reports · SIS-CEN ISO/TR 20416:2020

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

Status: Valid

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Standard Technical reports · SIS-CEN ISO/TR 20416:2020

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
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Scope
This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities. The output of this process can be used:
— as input into product realization;
— as input into risk management;
— for monitoring and maintaining product requirements;
— for communicating to regulatory authorities; or
— as input into improvement processes.
This document does not address market surveillance activities to be performed by regulatory authorities. Neither does it specify a manufacturer’s actions required by the applicable regulatory requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.

Subjects

Health care technology (01.040.11) Information technology, office machines (01.040.35) General (11.040.01) Quality management and corresponding general aspects for medical devices (11.110.10) General (11.120.01) IT applications in health care technology (35.240.80)


Buy this standard

Standard Technical reports · SIS-CEN ISO/TR 20416:2020

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Subscribe on standards - Read more Dölj
Price: 1 487 SEK
standard ikon pdf

PDF

Price: 1 487 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80023930

Edition: 1

Approved: 9/3/2020

No of pages: 56