Standards, Guidance & Notices
Showing 91–100 of 128
IEC
IEC 81001-5-1:2021
Health software and health IT systems safety, effectiveness and security — Part 5-1: Security activities in the product life cycle
Establishes a common framework for secure health software life cycle processes. Defines security activities and tasks to increase cybersecurity of health software.
Published: 2021-12-01
NIST
IR
IR
IR 8259B
IoT Non-Technical Supporting Capability Core Baseline
Non-technical supporting capabilities are actions a manufacturer or third-party organization performs in support of the cybersecurity of an IoT device. This publication defines an Internet of Things (IoT) device manufacturers’ non-technical supporting capability core baseline, which is a set of non-technical supporting capabilities generally needed from manufacturers or other third parties to support common cybersecurity controls that protect an organization’s devices as well as device data, systems, and ecosystems. The purpose of this publication is to provide organizations a starting point to use in identifying the non-technical supporting capabilities needed in relation to IoT devices they will manufacture, integrate, or acquire. This publication is intended to be used in conjunction with NISTIR 8259, Foundational Cybersecurity Activities for IoT Device Manufacturers and NISTIR 8259A, IoT Device Cybersecurity Capability Core Baseline.
Published: 2021-08-25
EU
MDCG
MDCG
MDCG 2021-13 rev.1
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
MDCG 2021-13 rev.1 — Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR — (July 2021)
Published: 2021-07-01
EU
MDCG
MDCG
MDCG 2021-18
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
MDCG 2021-18 — Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) — (July 2021)
Published: 2021-07-01
EU
MDCG
MDCG
MDCG 2021-17
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
MDCG 2021-17 — Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) — (July 2021)
Published: 2021-07-01
EU
MDCG
MDCG
MDCG 2021-10
The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
MDCG 2021-10 — The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices — (June 2021)
Published: 2021-06-01
EU
MDCG
MDCG
MDCG 2021-8
Clinical investigation application/notification documents
MDCG 2021-8 — Clinical investigation application/notification documents — (May 2021)
Published: 2021-05-01
EU
MDCG
MDCG
MDCG 2021-1 rev.1
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MDCG 2021-1 rev.1 — Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional — (May 2021)
Published: 2021-05-01
ISO
ISO 81001-1:2021
Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
Provides principles, concepts, terms and definitions for health software and health IT systems, covering safety, effectiveness and security across the full life cycle.
Published: 2021-03-01
NIST
IR
IR
IR 8259C
Creating a Profile Using the IoT Core Baseline and Non-Technical Baseline
The core baseline in NISTIR 8259A, IoT Device Cybersecurity Capability Core Baseline and the non-technical baseline in NISTIR 8259B, IoT Manufacturer Non-Technical Supporting Capability Core Baseline can be expanded upon based on more specific contextual information. Using source material with information pertinent to IoT device customers’ needs and goals, the central concepts of the NISTIR 8259 series can be used to guide the development of new elaboration on device cybersecurity capabilities an IoT device may need and the non-technical supporting capabilities that may be needed in relation to the IoT device. This process of expanding on the core baseline and non-technical baseline using additional contextual information is called profiling. A process by which readers of the NISTIR 8259 series can profile source documents is described in this publication.
Published: 2020-12-15
