Why Aren’t the Requirements Done?
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.
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Looking forward to presenting at MD&M with Roger Tang
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 lower manufacturing costs while still
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Newsletter V. 2019 Issue 4
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 healthcare and developing technology and
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How to set up a quality system for a medical startup
(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 work, a bad one hinders
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Invaluable for the team’s success
Aaron is excellent to work with and has been invaluable for the team’s success. His consistently identified issues and provided recommendations for resolving technical, process and regulatory challenges. Aaron is technically competent and is able to lead a cross functional group to resolution. Aaron is who I would call on to streamline technical or regulatory
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Newsletter V. 2019 Issue 3
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. This blog post summarizes the
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The Big Picture for Medical Device Risk Management
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 are we most worried about?
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Newsletter V. 2019 Issue 2
Have employees new to medical devices? I offer practical training on Medical Device Design Controls either on site or at a public workshop. Agile Design Controls This is a three part recorded webinar series that illustrates a flexible and rigorous approach to managing design controls for software-intensive medical devices. I teamed up with software experts
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Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices
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 with multiple retesting and with automatic
Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices
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 requirements with multiple retesting and