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New ISO Standards for Medical Devices

Taking the headache out of regulations while improving product safety and performance. From sticking plasters to MRI machines, medical devices help to save lives and improve the quality of everyday living for many. Some 500 000 technologies are already in existence and, with ageing populations, advances in medicine and the…

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Who Needs ISO 13485 Certification and Why?

If your company is involved in the design, manufacture, or distribution of medical devices, you may well need to gain certification against ISO 13485. This article explains what these internationally recognized requirements are, and why they might be important to your business.  About ISO 13485 Enforceable standards that promote good…

internet-of-medical-things
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The Internet of Medical Things is Changing Healthcare – How Safe are These Devices?

The face of the healthcare industry is changing. With the advent of Internet of Things technologies (IoT), in-body and wearable medical devices are now capable of reporting patient statistics in real time, administering medicine, autonomously delivering corrective stimulus and more. Patients receive alerts on their smartphones when their glucose levels…