ASTM F2077-22: Intervertebral Body Fusion Devices
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…
IAF MD 9:2022 – Changes in Medical Device Quality Management Systems
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
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…
Symbols for Medical Device Labels
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…
ANAB Recognized as an Accreditation Body for FDA ASCA Pilot Program
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…
Good Refurbishment Practices for Medical Imaging Equipment
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….
FDA Accreditation Scheme for Conformity Assessment (ASCA)
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….
ANSI/AAMI PB70 – Protective Apparel Liquid Barrier Requirements in Health Care
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…
ISO 10993 Biocompatibility and Risk Management
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…