The third edition of IEC 60601-1 will soon become de facto mandatory for certification of medical devices. This standard is unique, combining both product and process requirements into a single ...

Scarlet raised $50 million in Series B funding to expand its AI medical device certification platform and build what it ...

AI platform for Notified Bodies that checks medical device technical documentation against MDR, IVDR and ISO 13485 requirements at intake, helping reviewers identify deficiencies earlier and reduce ...

FormlyAI is pioneering the use of artificial intelligence in the certification of medical devices. Recently, the company announced that it has completed a seed funding round, raising $2 million. This ...

Scarlet raises $50M in Series B funding led by Headline to scale its AI-native certification body for medical devices across ...

PISCATAWAY, N.J.--(BUSINESS WIRE)--The first medical devices from companies including Ascensia have been certified under the new IEEE Medical Device Cybersecurity Certification Program. Test ...

MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, Netherlands, January 28, 2025 (Newswire.com) - Resyca BV, a pioneering leader in the ...

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 ...

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has announced the launch of a new electronic submission process for requesting export certificates for ...

Led by Headline, the funding will support the London-based company's expansion into the US and Asia-Pacific as it tackles ...

SOPHIA-ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered ...