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 »
Topic: Time to rethink developing software-intensive medical devices Understanding medical device software compliance starts with processes Accelerated change management with The Hub Managing product data in a platform (The Hub) enabled the product team to rapidly respond to unexpected design changes at the worst time (in the middle of V&V) while still generating rigorously controlled
Newsletter V. 2025 Issue 1 Read More »
Understanding all of the types of software at a medical device company is crucial to knowing what is required for validating, documenting, and controlling each type
Understanding the Software Landscape Read More »
Here’s a secret about understanding medical device software documentation: don’t start with a checklist of documents! Instead, start by understanding the processes necessary for compliance and the activities in those processes.
Secrets to Medical Device Software Documentation Read More »
I’m enjoying the New England snow! Warm wishes for a happy holiday season.
Warm Wishes from Sunstone Pilot Read More »
SaMD SaMD (Software as a Medical Device) products are at the forefront of some of the most innovative new healthcare technology but present particular challenges to medical device companies. Understanding and tackling these challenges will go a long way to making your next SaMD product a success. Some of the key challenges are:Managing frequent changes
Newsletter V. 2024 Issue 3 Read More »
