medical devices Archives

Surgeon in health care facility picking up medical devices that adhere to risk management requirements in ISO 14971:2019.

ISO 14971:2019–Risk Management To Medical Devices

April 18, 2023April 11, 2023Alexandra Schirn

Flint knives, saws, and drills were used for surgery, amputation, and trepanation during the Upper Paleolithic and Mesolithic times in 6000 BCE. These were the […]

Medical devices in health care facility adhering to security risk management in ANSI/AAMI SW96:2023 and ISO 14971:2019.

ANSI/AAMI SW96:2023—Medical Device Security

April 17, 2023April 11, 2023Alexandra Schirn

The steps that involve manufacturing, regulation, planning, assessment, acquisition, and management of medical devices are complex but essential to guarantee their quality, safety, and compatibility […]

Young female doctor wearing medical face mask adhering to ASTM F2100-23 before surgery.

Standard for Medical Face Masks, ASTM F2100-23

April 13, 2023April 14, 2023Brad Kelechava

Some 16 million people work in the healthcare sector, doing the work that keeps the rest of us alive. Personal protective equipment (PPE), such as […]

Dentist holding a dental implant model, adhering to ANSI/ADA 173-2019.

ANSI/ADA 173-2019: Dental Implants Designation System

November 7, 2022January 9, 2023Alexandra Schirn

Here are some facts about missing teeth you should know: the average American has lost 12 teeth by age 50; 69% of American adults are […]

Intervertebral body fusion device, adhering to testing methods specified in ASTM F2077-22.

ASTM F2077-22: Intervertebral Body Fusion Devices

October 7, 2022January 17, 2023Alexandra Schirn

You are taller in the morning and in outer space. The lack of gravity from lying down to sleep or being in outer space causes […]

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

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

June 15, 2022January 10, 2023Brenda Bissell, Senior Accreditation Manager

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 […]

Medical Advancements That Promote Patient Independence

January 10, 2022January 28, 2022Guest Contributor

This infographic was created by Coapt Engineering Here are some medical and technological breakthroughs that help patients remain independent. Remote Patient Monitoring Equipment Advances in […]

Stethoscope on wood adhering to ISO 15223-1:2021 for symbols on medical device labels.

Symbols for Medical Device Labels

July 13, 2021January 17, 2023Brad Kelechava

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 Recognized as an Accreditation Body for FDA ASCA Pilot Program

February 10, 2021April 8, 2021Keith Klemm, Senior Manager of Accreditation

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.

Good Refurbishment Practices for Medical Imaging Equipment

January 6, 2021January 23, 2023Brad Kelechava

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. […]