Compiling a Hazards and Harms List (HHL) at the beginning of medical device development is a simple technique to improve all risk management activities for that product (or family of products). Have you ever been in an audit trying to explain to the auditor why the severity of a particular harm is rated differently in […]
Using a Hazards and Harms List to Improve Risk Management Read More »
“Don’t depend on documents to manage your documentation!” Product teams developing a new medical device need to produce a lot of documentation but that doesn’t mean they should use the documents to manage all the product data, especially for software-intensive medical devices. “Are these the latest software requirements? Who has the latest draft test protocol?”
Platform Approach to Managing Development of Medical Devices Read More »
What are the correct design control phases for medical device development? To properly answer that question we have to step back and look at the bigger picture of product development processes and medical device regulations. There’s a simple answer to the question if we are only talking about your company and its quality system–the correct
Creating the Correct Design Control Phases Read More »
September 2025 Newsletter – AI tools for Medical Device Development
Newsletter V. 2025 Issue 3 Read More »
Describes the shortcomings of using DFMEA as the first and only risk assessment tool for medical device risk management and recommended alternatives. Includes in-depth discussions by subject matter experts.
What’s Wrong with DFMEA? Read More »
Here are some things I’ve been working on lately that I think will be valuable to others working with medical devices. This issues includes Cybersecurity Documentations, AI for Medical Device Compliance and a Rapid Compliance with IEC 62304 Case Study.
Newsletter V. 2025 Issue 2 Read More »
CLIENT Small Medical Device Manufacturer (<200 employees) Company Stage: Two hardware products launched; working on their first digital health product (SaMD) CHALLENGES Client had no experience with mobile or cloud software; relied 100% on development partner Software development partner had no experience with medical devices and regulations; they were making undocumented and uncontrolled changes to
Rapid Compliance with the IEC 62304 Medical Software Standard Read More »
Agile medical device development can provide tremendous benefits but agile methods must be modified for successful hardware development and regulatory compliance. The MAHD Framework provides a proven process with these modifications.
Secrets to Unlocking Agile Benefits for Medical Device Development Read More »
Medical device design controls are not a separate set of activities run in parallel to product development–they are a central part of development.
Underestimating and Overestimating Design Controls Read More »
CLIENT Small Medical Startup (<10 employees) Company Stage: Developing digital health product (SaMD) CHALLENGES Client staff consisted of physicians and engineers who had no experience with medical devices and regulations Aggressive timeline for software development, testing, and FDA submission No quality system and no head of quality SOLUTION Used a staged implementation for quality system
Starting Up Design Controls for SaMD Read More »
