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Current

AAMI/ISO 13485:2016, A Practical Guide

Medical Devices—A Practical Guide, Advice from ISO/TC 210

AAMI

Standard

Publication Date: 2017-01

Category: Quality Systems/Regulatory Affairs

Name: AAMI/ISO 13485:2016, A Practical Guide

Pages: 0

Valid: Yes

Starting from € 142.00

See the preview

AAMI has adopted this companion handbook to ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. This resource replaces ISO 14969. AAMI/ISO 13485:2016, Medical devices—A practical guide, offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.

Annotation

Standard Evolution

ICS

International Classification for Standards (ICS) is an international classification system for technical standards.

The ICS is a hierarchical classification organized on three levels.

Level 1 covers the main fields of activity in standardization, e.g. road vehicle engineering, agriculture, metallurgy.

Each field has a two-digit notation, e.g.

  43    Road Vehicle Engineering

The main fields are subdivided into groups (level 2). The notation of a group consists of the field notation and a three-digit group number, separated by a point, e.g.

  43.040    Road vehicle systems

Some groups are further divided into sub-groups (level 3). The notation of a sub-group consists of the group notation and a two-digit number, separated by a point, e.g.

  43.040.20 Lighting, signaling and warning devices

You can identify the ICS code of your interest by typing the code or a keywordword in the dropdown ICS field, and by selecting one of the filtered results.

Search also in the summary/description of the standard

By flagging this control, the search for keywords will not be limited to the Standard Number and Title fields, but will also be performed in the Abstract of the standard.

This way, you will get more results.

You should use this option when you can not find the desired result with the standard approach and it is necessary to extend the scope of the search: by increasing the number of results, you will increase the number of non-relevant elements, as well.