Guidance for EU MDR Software as a Medical Device (SaMD)

Guidance for EU MDR Software as a Medical Device (SaMD)

£150.00

This document will help you understand the definition of SaMD under the 1993 Medical Device Directive as well as the 2017 Medical Device Regulation, how to classify your software and which conformity route to take in order to become complaint with the new MDR.

A preview of the Guidance for EU MDR Software as a Medical Device (SaMD) is available here:

You may purchase the full document in convenient Microsoft Word format including instructions for use below.

Description

Software as a Medical Device (SaMD) is any software that is intended to be used as a way to diagnose, monitor or aid in the treatment of a medical condition. For this reason, SaMD is governed by the directives and regulations concerning medical devices in the European Union.

This document will help you understand the definition of SaMD under the 1993 Medical Device Directive as well as the 2017 Medical Device Regulation, how to classify your software and which conformity route to take in order to become complaint with the new MDR.

Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.

Our consultants are available, should you need further assistance in completing the documentation.