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1Blog Post

Ensuring FDA Compliance for Your Digital Health Solution

Over the last decade, digital health solutions have become increasingly important, powering revolutionary developments in areas such as robotics, genomics, diagnostics, patient/provider interactions, and many more. In our recent webinar with MDM Engineering Consultants and BeanStock Ventures, we talked about critical standards and best practices to follow. Attendees also heard critical insight from industry leaders […]

2Blog Post

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

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, […]

4Blog Post

2022 Automotive Predictions: Modernizing Development, Maintaining Compliance, and the Growing Autonomous Market

2022 Automotive Predictions  In many ways, 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of […]

5Blog Post

A Guide to Understanding ISO Standards

If you’ve worked in product development for any time at all, you’ve probably heard the term “ISO” used in conjunction with the terms “standards” and “compliance” (along with a variety of four- and five-digit numbers). But what does that all mean, and how does it affect you? In this article, we will provide you with […]

6Blog Post

What is FMEA? Failure Mode and Effects Analysis Process Overview

What is FMEA (Failure Mode and Effects Analysis)? Failure Mode and Effects Analysis (FMEA) is a structured process for determining potential risks and failures of a product or process during the development phase. FMEA teams examine failure modes—those potential points of failure in a product or process — and what the failure effects (risks, harm, […]

7Blog Post

Toys to Tools – Keeping Pace with eVTOL Certification Standards

Toys to Tools – Keeping Pace with eVTOL Certification Standards Today’s market for electric vertical takeoff and landing (eVTOL) is one of the most innovative and fast-moving in the aerospace industry, so keeping pace with ever-changing eVTOL certification standards is no easy endeavor. eVTOL Applications The military led the way in eVTOL by transforming drones […]

8Blog Post

Simplify Audit Documentation by Leveraging the Power of an Itemized Database

Simplify Audit Documentation by Leveraging the Power of an Itemized Database How to enhance efficiency, auditability, and stay ahead of the competition with Jama Connect® for Medical Device Development In the current landscape of medical device and life sciences development — in addition to facing relentless pressures to innovate, remain competitive, and release quality products […]

9Blog Post

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

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 […]

10Blog Post

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

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 […]