ISO 13485 training No medical procedure comes without risk, but this can be reduced through effective risk management and regulation of medical devices. A medical device is any instrument or machine used to diagnose, prevent, or treat medical conditions and diseases. ISO 13485 is a global standard used to audit businesses that use devices for…
How to Comply with the New ISO 13485 2016 Standard? ISO 13485 2016 (or EN ISO 13485 2016 for Europe) is the latest standard for medical devices. It was published in July 2016, and it has a lot of changes from ISO 13485:2003. ISO 13485 2016 includes new requirements for quality management systems and documentation…
Keeping Your Medical Devices Safe with the Latest Cybersecurity Solutions In the ever-changing world of medical devices, one thing is for sure: the FDA and other regulators have been taking a much closer look at what needs to be done in order to keep patients safe in this connected world. In fact, the FDA’s guidance…
“Software as a Medical Device (SaMD)” – A New Trend in Healthcare Software as a Medical Device (SaMD) is an innovative trend in healthcare. SaMD software bridges the gap between medical devices and information technology, using software to improve patient care. It has been growing steadily over the past few years, but only recently have…
Free access to ISO 13485 standard, other medical device and personal protection equipment standards To sustain the campaigns taking care of the impact of COVID-19, the International Organization for Standardization (ISO) has made a few of its standards supporting the assessment of medical devices as well as personal protection equipments used in healthcare setups easily…