AAMI TIR12:2020 (R2023)— A Guide for Device Manufacturers
Medical device manufacturers are required to design and build quality into their products. This means that they must have processes and procedures in place to ensure…
ISO 14971:2019–Risk Management To Medical Devices
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…
ANSI/AAMI SW96:2023—Medical Device Security
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…
Changes in the New ISO 15189:2022
The objective of ISO 15189:2022- Medical Laboratories – Requirements For Quality And Competence is to promote the welfare of patients and satisfaction of laboratory users…
ISO/IEC 27005:2022 – Information Security Risk Management
People often say that the world is changing, and technology is painted as the catalyst for this rapid progression. In truth, the world has always…
The Importance of Collaboration for Certifications
Workcred has developed a set of case studies that reveal just how powerful collaboration is to certifications. In fact, collaboration among key stakeholders can have…
ANSI/ASSP Z590.3-2021: Prevention through Design Guidelines
Sentient beings seek pleasure and avoid pain. The latter characteristic, at least in animals with a nervous system, manifests in reflexes. Involuntary movements act as…
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…
IEC 31010:2019, International Standard on Risk Assessment
In times of uncertainty, it’s good to know IEC and ISO maintain a risk management toolbox, with standards like IEC 31010 and ISO 31000, that…