As we come to the end of 2020, a year that can only be described as stormy, we wanted to send you a quick note of appreciation. We are grateful for our connection and the opportunity to work together. Thank you for your support, your business, and your resilience in [...]
Best practices for medical device HW testing are not best for SW testing Medical device development teams often ask me for help with software V&V. Even though they have their hardware development under control, these teams keep encountering software testing problems and the corresponding compliance documentation. Frequently, it’s because their [...]
Writing and managing requirements for new product development is challenging and multi-faceted. Tips to help your team on the right path to good requirements.
The Two Mindsets of Successful Medical Device Development Modern product development teams face increasing challenges in bringing new medical devices to market: greater product complexity, tighter budgets, and more regulatory scrutiny. Agile and Lean practices, properly implemented, can enable medical device companies to accelerate product development, improve product quality, and [...]
Medical Device Startups Startups are the heart and blood of the medical device industry. They are driving innovation and making healthcare more effective and more personalized. Because of this, startups are well positioned for an emerging ecosystem of interconnected medical technology and services. Investors see the enormous opportunities in improving [...]
(or “achieving compliance without bringing everything to a crawl”) Creating a quality system is fundamental for a medical startup because 1) it’s the law, and 2) it ensures a safe, reliable product. While a good quality system encompasses best practices at a company and makes the most of each employee’s [...]
Risk Management Risk management plays a central role in medical device development but many medical device professionals I’ve worked with over the years seem to have missed the forest for the trees. They are more focused on the details of risk management compliance than the central goal of product safety. [...]
Understanding all the details of risk analysis methods and compliance with the ISO 14971 risk management standard can be quite complicated but fundamentally, for development of a new medical device, risk management is about answering these seven key questions: What are all the possible things that could go wrong? What [...]
https://vimeo.com/333499493 This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of requirements [...]
Available Now This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of [...]