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Hospital hallway with medical devices following ISO 13485 quality management and accredited with IAD MD 9:2022 requirements.
ANAB | Management Systems

IAF MD 9:2022 – Changes in Medical Device Quality Management Systems

ByBrenda Bissell, Senior Accreditation Manager June 15, 2022May 23, 2025

IAF MD 9:2022, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems specifies normative criteria for conformity assessment bodies (CABs) auditing…

Stethoscope planted over blue graph representing patient technology.
ANSI | Health Care | Medical Devices

Medical Advancements That Promote Patient Independence

ByGuest Contributor January 10, 2022May 28, 2025

Here are some medical and technological breakthroughs that help patients remain independent. Remote Patient Monitoring Equipment Advances in communication technologies have been especially beneficial to…

Stethoscope on wood adhering to ISO 15223-1:2021 for symbols on medical device labels.
ANSI | Labels and Symbols | Medical Devices

Symbols for Medical Device Labels

ByBrad Kelechava July 13, 2021May 28, 2025

A voluntary consensus standard can result in the summation of the best existing practices and techniques in an industry that were in use prior to…

Emergency room with carefully placed medical devices accredited to the FDA ASCA Pilot Program.
ANAB | Laboratory

ANAB Recognized as an Accreditation Body for FDA ASCA Pilot Program

ByKeith Klemm, Senior Manager of Accreditation February 10, 2021May 29, 2025

ANAB has been recognized as an accreditation body (AB) for the U.S. Food & Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot program…

Patient undergoes red light of PET scan and CAT scan technology refurbished to IEC 63077 medical imaging requirements.
ANSI | Health Care | Medical Devices

Good Refurbishment Practices for Medical Imaging Equipment

ByBrad Kelechava January 6, 2021June 10, 2025

The medical industry follows a pattern of continuous advancement to meet patient needs, with innovations in medical technology plentiful at almost any point in time….

Vacant operating room has accredited testing laboratory products, via Accreditation Scheme for Conformity Assessment (ASCA).
ANAB | Laboratory

FDA Accreditation Scheme for Conformity Assessment (ASCA)

ByMelanie Ross, Technical Products Developer October 30, 2020May 29, 2025

The U.S. Food & Drug Administration (FDA) has announced recognized accreditation bodies (ABs), including ANAB, for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program….

Woman in an operating room with personal protective equipment on that is specified in ANSI/AAMI PB70:2012
ANSI | Medical Devices

ANSI/AAMI PB70 – Protective Apparel Liquid Barrier Requirements in Health Care

ByBrad Kelechava April 9, 2020May 29, 2025

Patient care is a hands-on process, but this contact places unique stresses on healthcare professionals. Infection control practices, such as protective apparel, help protect patients…

Blue medical device in hallway biologically evaluated to ISO 10993 risk management.
ANSI | Medical Devices

ISO 10993 Biocompatibility and Risk Management

ByBrad Kelechava April 7, 2020June 5, 2025

Burgeoning alongside advancements in the medical industry itself, innovations in medical devices have blossomed over the past few centuries. Even before a rolled up notebook…

ISO 14117:2019 electromagnetic compatibility (EMC) test protocols active implantable medical devices Pacemaker
ANSI | Medical Devices

ISO 14117:2019, EMC Tests for Implantable Medical Devices

ByBrad Kelechava October 25, 2019June 5, 2025

An international standard, ISO 14117:2019, outlines electromagnetic compatibility (EMC) test protocols for various active implantable medical devices. The heart typically pumps at 60-100 beats per…

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