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 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 ...

Predetermined Change Control Plans (PCCPs) are quickly becoming a critical tool for medical device teams, enabling ...

Cybersecurity has evolved from a secondary software concern to a core design requirement in connected medical devices. The rapid growth of the internet of medical things (IoMT) has expanded the attack ...

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 ...

The world of medical devices is rapidly changing. In place of disconnected, simple medical devices, a new world of complex software both on and off the now-connected device is providing a larger ...

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, ...

Bringing a medical device to clinical trial is one of the most significant milestones in any development journey. Yet terms ...

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 ...

A monthly overview of things you need to know as an architect or aspiring architect. Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with ...

Imaging Contract Research Organization (iCRO) from Bayer offering tailored services that will span the entire imaging study cycle from concept to completion Supporting early research through Phase IV ...