Propel your career forward with an accredited graduate certificate. Get the skills and competences to innovate, evaluate, and regulate biomedical devices and technologies with the graduate on-campus ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

GREEN BAY, Wis.--(BUSINESS WIRE)--Pioneer Metal Finishing, LLC ("Pioneer"), is pleased to announce the ISO 13485 certification of its Medical Center of Excellence facility in South Bend, IN. “This ...

WAKEFIELD, Mass.--(BUSINESS WIRE)--Optikos Corporation announced today the Company has expanded its ISO certification to include ISO 13485:2016, indicating that the Optikos Quality Management System ...

An electronics manufacturer in Akron has been given new life and is setting out to chase the medical device market, thanks to some work and investment by its new owners and an important new ISO ...

Linus Health, a digital health company focused on early detection of Alzheimer's and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) ...

In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and ...

The CE Marking approval indicates that a medical device meets the requirements of the European Medical Devices Directive. Until now, Materialise’s personalized devices made use of the custom-made ...

The certification expands access to Freedom60 and FreedomEDGE infusion pumps for growing SCIg prefilled syringe use.

Teltonika’s TeltoHeart, a multifunctional smart wristband system developed in cooperation between Lithuanian industry and universities has been given the CE MDR (Class IIa) medical device ...