Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

Early-stage development in technology usually follows a “fail fast” philosophy: build something simple, observe outcomes, and ...

The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Formal methods provide a rigorous mathematical foundation for the specification, development and verification of medical device software. This approach enhances both reliability and safety, which are ...

In-house and private practice counsel set out the challenges and opportunities of protecting software in medical devices and software as a medical device Medical device manufacturers have been ...

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WEST LAFAYETTE, Ind.--(BUSINESS WIRE)--MED Institute obtained FDA qualification of their MDDT (Medical Device Development Tool) for virtual MRI safety evaluations, to determine if MRI imaging is safe ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...