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 […]
Risk Management
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 […]
ISO 19011:2018 – Auditing Management Systems Guidelines
A new standard revision, ISO 19011:2018 – Guidelines for auditing management systems, has been released. Harmonizing ISO Management Systems Standards ISO management systems standards are […]
Changes to ISO 10005:2018 – Revised Standard for Quality Plans
An international standard for quality management activities has been revised: ISO 10005:2018 – Quality management – Guidelines for quality plans. Due to its significance and […]