Industry: Medical Device & Life Sciences

The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

February 3, 2022 in /by

What is Digital Health? Digital health merges digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery to make medicine more personalized and precise. Digital health is a broad category that includes: Mobile health (mHealth) Health information technology (IT) Wearable devices Telehealth Telemedicine Personalized medicine Digital health technologies use: Computing […]

Key Takeaways: What the New Medical Device Regulations (EU MDR) Mean for You

December 28, 2021 in /by

In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development.  As medical device technologies have rapidly advanced in recent years, regulations governing definitions, testing, and post-market activities have struggled to […]

Top Signs Your Design Review Process Is Hurting Your Business

December 9, 2021 in /by

Design review processes and their impact on product development. Development organizations typically have a predefined set of formal design reviews that are held throughout the development process. A design review usually includes assessing design input requirements for adequacy, assessing the adequacy of a design to fulfill design input requirements, and verification/validation-related reviews. When done correctly, […]

Complying with FDA Design Control Requirements Using Requirements Management Principles

November 11, 2021 in /by

Complying with FDA Design Control Requirements Using Requirements Management Principles Mercedes Massana: So agenda for today is we’re going to talk a little bit about the design controls and what they are. We’re going to talk about requirements management and what that is. And then we’re going to talk about how the two relate to […]

3 Ways Requirements and Risk Management Continue After Market Launch

November 9, 2021 in /by

Congratulations!  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.  […]

What’s a Design History File, and How Are DHFs Used by Product Teams?

November 3, 2021 in /by

In the competitive world of medical device development, medical device companies can’t afford to lag behind the pack. Streamlining the design and approval process is vital to getting products to market in a timely manner. Proper documentation is key to a smooth approval process. One essential ingredient to medical device documentation is the Design History […]

Why Startup Medical Device Companies Should Prioritize Requirements and Risk Management Before QMS

October 26, 2021 in /by

As 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 […]

Five Key Design Control Practices that Improve Compliance and Help Develop Better Products

October 7, 2021 in /by

Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of the five key takeaways for implementing design controls and achieving success in commercializing medical devices: Design Controls not only help achieve regulatory compliance, […]