🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BSI PD CEN ISO/TR 20416:2020

BSI PD CEN ISO/TR 20416:2020

$198.66

Medical devices. Post-market surveillance for manufacturers

Published By Publication Date Number of Pages
BSI 2020 52
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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:

  1. as input into product realization;

  2. as input into risk management;

  3. for monitoring and maintaining product requirements;

  4. for communicating to regulatory authorities; or

  5. 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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Purpose of post-market surveillance process
11 5 Planning of post-market surveillance
5.1 General
12 5.2 Scope of the post-market surveillance plan
13 5.3 Objective of the post-market surveillance plan
15 5.4 Responsibilities and authorities
16 5.5 Data collection
5.5.1 Data sources
5.5.2 Defining data collection methods
17 5.5.3 Developing the data collection protocol
5.6 Data analysis
5.6.1 General
5.6.2 Considerations concerning planning the data analysis
18 5.6.3 Methods for data analysis
19 5.7 Report on data analysis
20 5.8 Interface with other processes
6 Review of the post-market surveillance plan
6.1 Purpose of the review
6.2 Criteria
21 6.3 Review
22 Annex A (informative) Examples of data sources
33 Annex B (informative) Examples of data analysis methods
39 Annex C (informative) Examples of post-market surveillance plans
51 Bibliography

Related products

BSI PD CEN ISO/TR 20416:2020
$198.66