Standards, Guidance & Notices
Showing 71–80 of 128
JIS
Std
Std
JIST810015-1
JIS T 81001-5-1:2023 Health software and health IT system safety, efficacy and security - Part 5-1: Security - Activities in the product lifecycle (equivalent to IEC 81001-5-1:2021)
This JIS standard specifies cybersecurity activities that medical device manufacturers must implement in addition to the software lifecycle processes defined in JIS T 2304, corresponding to IEC 81001-5-1:2021. The document establishes requirements for managing security risks throughout the product lifecycle, addressing threats related to unauthorized access, data integrity, and system availability. Enacted on February 25, 2023, and effective from April 1, 2024, this standard was developed by JEITA (Japan Electronics and Information Technology Industries Association) as a draft originator. The standard is positioned as a conformance specification for Article 12, Paragraph 3 of Japan's Medical Device Basic Requirements Standards (Yakuhin Kikai Kihon Youken Kijun). Manufacturers should integrate the cybersecurity activities outlined herein with their existing software development processes to ensure comprehensive protection against evolving security threats throughout the device lifecycle.
Published: 2023-02-25
NIST
FIPS
FIPS
FIPS 186-5
Digital Signature Standard (DSS)
This standard specifies a suite of algorithms that can be used to generate a digital signature. Digital signatures are used to detect unauthorized modifications to data and to authenticate the identity of the signatory. In addition, the recipient of signed data can use a digital signature as evidence in demonstrating to a third party that the signature was, in fact, generated by the claimed signatory. This is known as non-repudiation since the signatory cannot easily repudiate the signature at a later time.
Published: 2023-02-03
AAMI
TIR
TIR
AAMI TIR97:2019/(R)2023
Principles for medical device security — Postmarket risk management for device manufacturers
Technical information report providing guidance on postmarket security risk management for medical devices within the ISO 14971 safety risk management process. Designed for use with AAMI TIR57:2016. Covers PSIRT establishment, vulnerability disclosure policy, and coordinated vulnerability disclosure (CVD) frameworks. Closely aligned with FDA postmarket cybersecurity guidance. Published 2019, reaffirmed 2023.
Published: 2023-01-31
AAMI
TIR
TIR
AAMI TIR57:2016/(R)2023
Principles for medical device security — Risk management
Technical information report providing guidance on information security risk management for medical devices within the ISO 14971 safety risk management process. Incorporates expanded risk management concepts from IEC 62443, presenting practical methods for threat modeling and security risk assessment. Directly referenced by FDA's 2023 final cybersecurity guidance. Complementary to IEC 81001-5-1. Originally published 2016, reaffirmed 2023.
Published: 2023-01-13
EU
MDCG
MDCG
MDCG 2022-19
Performance study application/notification documents under Regulation (EU) 2017/746
MDCG 2022-19 — Performance study application/notification documents under Regulation (EU) 2017/746 — (December 2022)
Published: 2022-12-01
EU
MDCG
MDCG
MDCG 2022-18
MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
MDCG 2022-18 — MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate — (December 2022)
Published: 2022-12-01
JFMDA
Notice
Notice
jaame-well-known-matters-1
Clinical Evaluation Report Documentation Examples (1) and (2)
JAAME Clinical Evaluation Committee documentation examples (November 1, 2022) illustrating proper clinical evaluation report formatting and content based on the 2020 guidance on clinical evaluation report and consultation material preparation.
Published: 2022-11-01
JFMDA
Notice
Notice
jaame_20221020_SaMDMedDevクラス1
Handling of Software as a Medical Device (SaMD) Class I Products (October 20, 2022)
JAAME SaMD Regulatory Response Sub-working Group presentation summarizing Class I SaMD product handling procedures, classification criteria, and regulatory compliance requirements for software-based medical device manufacturers.
Published: 2022-10-20
JFMDA
Notice
Notice
jaame_20221020_SaMD該当性解説書
Commentary on SaMD Medical Device Applicability Guideline - JAAME Edition Version 1.0 (October 20, 2022)
JAAME interpretive guidance (Version 1.0, October 20, 2022) clarifying software medical device applicability determinations and classification procedures to facilitate manufacturer understanding of regulatory requirements.
Published: 2022-10-20
EU
MDCG
MDCG
MDCG 2020-10
Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form
MDCG 2020-10 — Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form — (October 2022 October 2022)
Published: 2022-10-01