The main market opportunities lie in mastering regulatory decisions for software innovations in healthcare, particularly for digital therapeutics and AI. Navigating complex global regulations ...

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 ...

The data reveals key market opportunities in enhancing compliance through expertise in PMS, PMCF, and vigilance for digital health technologies. Emphasizing real-world data, risk management, and ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

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 ...

The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...

Data drives modern healthcare. Wearables can continuously monitor patients living at home while point-of-care medical technologies stream data into databases. Meanwhile, connected systems create ...

In 2023, the MedTech custom medical software development market will continue growing with projected revenue of $579.40 billion, keeping developers busy. New solutions provide companies with the tools ...

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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 ...