[GUIDE] ISO 13485 for Medical Device Development
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
Archive for category: Risk Management Page 2
MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks
July 26, 2022 in Risk Management Medical Device & Life Sciences /by Jama SoftwareJama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from HealthITSecurity – MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks – which was originally […]
[Webinar Recap] Understanding Integrated Risk Management For Medical Device
July 12, 2022 in Risk Management Medical Device & Life Sciences /by Jama SoftwareIn this blog, we recap the “Understanding Integrated Risk Management for Medical Device” webinar. Companies involved in developing medical devices understand the importance of risk management, but their approaches can vary significantly in terms of the time it takes to manage risk, the ability to connect risks to specific requirements and tests, and the capacity […]
[Webinar Recap] Lessons Learned for Reducing Risk in Product Development
February 28, 2022 in Risk Management /by Jama SoftwareIn this blog, we will recap a webinar on reducing risk in product development Over the last 20 years, product development complexity has expanded exponentially, creating innovations in areas such as space tourism, autonomous vehicles, satellite communications, and more. In this webinar, Kemi Lewis, Senior Consultant at Jama Software, will demonstrate how Jama Connect© creates Live […]
Why Your Medical Device Risk Management is NOT Effective
February 16, 2022 in Risk Management Medical Device & Life Sciences /by Steven MeadowsMedical Device Risk Management Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a […]
3 Ways Requirements and Risk Management Continue After Market Launch
November 9, 2021 in Risk Management Medical Device & Life Sciences /by Jama SoftwareCongratulations! 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
October 26, 2021 in Risk Management Medical Device & Life Sciences /by Michelle WuAs 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 […]
With Jama Connect®, TELEDYNE e2v Improves Communication, Review Cycles, and Efficiencies, Reducing Risk in the Development Process
October 12, 2021 in Risk Management Industrial Manufacturing & Machinery /by Decoteau WilkersonIn this post, we look at how Teledyne e2v leverages Jama Connect for improved communication and better risk management. Teledyne e2v is a global leader in specialized components and subsystems for innovative solutions in medical, science, aerospace, defense, and industrial applications. Over 1600 employees in countries across Europe, America, and Asia. As a result of their […]
Product Development Process: How Confident Are You That You Are Not at Risk?
November 6, 2020 in Product Development & Management, Risk Management /by Marc OsofskyIn this post, Jama Software’s CEO discusses how living requirements can help reduce the risk of negative outcomes in the product development process.
Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device
August 18, 2020 in Risk Management Medical Device & Life Sciences /by Jama SoftwareIn this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.