SA HB 13485:2020
AS ISO 13485:2017 - Medical devices - A practical guide

Standard No.
SA HB 13485:2020
Published By
SCC
Latest
SA HB 13485:2020
 
Scope
The objective of this document is to provide additional insight and understanding of the requirements in AS ISO 13485:2017, Medical devices - Quality management systems - Requirements for regulatory processes.

SA HB 13485:2020 history

Standard and Specification

BS PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European CEN ISO/TR 24971:2020 Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020 ISO/TR 24971:2020 Plus Redline Medical devices - Guidance on the application of ISO 14971 SN-CEN ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971 (ISO/TR 24971:2020 BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices DIN EN ISO 13485:2010 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009


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