New Search

Can't find what you're looking for? Try another search!

120 search results for:

1Blog Post

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

/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 […]

2Blog Post

Top Signs Your Design Review Process Is Hurting Your Business

/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, […]

3Blog Post

3 Ways Requirements and Risk Management Continue After Market Launch

/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.  […]

4Blog Post

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

/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 […]

5Blog Post

Software as a Medical Device (SaMD): Four Key Development Best Practices

/in /by

This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants.  SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or […]

6Blog Post

Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management

/in /by

One of the early steps I advise my clients to take when developing their medical device is to determine the class and classifications of their medical device. In conjunction with the complexity of the device, understanding the class and classification sets the foundation for your product development timeline and effort.  This post gives a basic […]

7Blog Post

[Webinar Recap] The Costly Impact of Ineffective Requirements Management in the Medical Device Industry

/in /by

In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements management in the medical device industry Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems. However ineffective and inefficient, the industry still relies overwhelmingly on static […]

8Blog Post

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

/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, […]

10Blog Post

Lessons Learned: Medical Device Development Through COVID-19 and Beyond

/in /by

Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s Chief Product Officer. In the fall, I wrote about how the medical technology industry has struggled to keep pace with other, similar industries. In the piece, I discuss how important it is […]