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 ...

Speed and agility have become critical in the delivery of new therapies, devices and drugs. Siemens has sponsored this post. Written by: Dale Tutt and Jim Thompson, Siemens Digital Industries Software ...

Oura's ISO 13485 certification is the smart ring company's latest move to expand its software-as-a-medical-device (SaMD) ...

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 ...

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 ...

ISO 13485 certification reflects the quality management system Oura has put in place to manage risk, support product safety, incorporate feedback, and improve its products over time. It also provides ...

The goal of medical device software development should be to select a process and architecture that ensure a safe and effective product. The methods utilized to achieve this goal differ among medical ...

Research and Markets has opened registration for the live online course Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations. The course is organized by IPI Academy and runs ...

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

An ISG Provider Lens® report says U.S. medical technology companies are shifting to software-defined ecosystems that evolve ...

URA, a leading health intelligence platform and maker of the world’s smallest smart ring, today announced that its quality ...