medical device

  • 3 Ways Requirements and Risk Management Continue After Market Launch

    Congratulations!  Your organization has gained regulatory approval and launched its medical device product.  The ‘History’ in Design History File may elicit impressions that all those design and development requirements are now done and considered part of the past.  However, several components of the DHF continue as a reference and evolve, including requirements and risk management. …

  • Why Startup Medical Device Companies Should Prioritize Requirements and Risk Management Before QMS

    As a medical device product development consultant, I often see start-up companies having trouble deciding what to prioritize – design controls and risk management or the quality management system (QMS).  And what they mean specifically is, which software systems should the company invest in first – the requirements and risk management solution that will aid…

  • [SPOTLIGHT] ON Semiconductor Focusing on Ethics, Employees, and Community During Uncertain Times

    In this post, we applaud the work that ON Semiconductors is doing during the pandemic, and the way they are prioritizing ethics, employees, and community during these uncertain times. 

  • [SPOTLIGHT] Abbott Labs’ Innovative Product Development Creates Breakthrough in Fast, Affordable COVID-19 Testing

    Innovative product development is imperative to solving this pressing worldwide challenge: slowing the spread of COVID 19. See how Abbott Labs is rising to the challenge.

  • Part IV: Connecting Design Controls, Including Design Inputs, Design Outputs and Verifications 

    In the previous blog of this series, we talked about the application of systems engineering principles to the design inputs process. In this post, we explore how the Jama Connect™ for Medical Device Development procedure guide describes connecting design inputs with subsequent processes: Design Outputs and Verifications. By supporting these processes in a single system and…

  • Watch Webinar: Aligning People, Process, and Technology to Support Medical Device Development

      Medical devices have become increasingly complex, connected, and integrated systems. Yet many engineering teams still rely on documents and spreadsheets to manage development, risk assessments, and testing of devices to provide evidence of design control. This approach is no longer viable. Register to watch Axendia’s President Daniel R. Matlis and Jama Software’s VP of…

  • Part III: Design Inputs in Jama Connect for Medical Device Development 

    As medical device manufacturers develop complex products, they require a product development approach capable of managing that complexity.    At the same time, manufacturers must continue to ensure compliance and alignment with regulations and standards. These define requirements that ensure safety and quality and reduce risk—but ultimately do not prescribe specific tools or techniques.   This is especially apparent in design control activities. Regulatory requirements define the “what” for compliance but leave the “how” to the manufacturer, as long the procedures describing…

  • Expedite Medical Device Launches with Effective Collaboration

    Editor’s Note:  In a time where remote collaboration and distributed teams are quickly becoming the norm rather than the exception, we're proud to share this post on the value of effective collaboration around medical device design and product development. This article was originally published here on May 5th, 2020 by MedTech Intelligence and written by…

  • What is Medical Device Risk Management?

    Building and then bringing a medical device to market as quickly as possible—all while preserving acceptable levels of quality and regulatory compliance—requires adept medical device risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks…

  • Industry Roundup: Medical Device Technology Advances in the Wake of Cybersecurity Concerns

    Despite ongoing concerns about cybersecurity, the medical device landscape has seen some amazing advances even just this year.