Compliance with regulatory standards is the number one priority for every medical manufacturer. Ensuring pipelines are secure and compliant doesn’t just ensure safety, but it results in better quality products. When a startup medical manufacturing company contacted...
Medical Device Engineering
The FDA UDI Rule: 5 Things You Need to Know
The release of the FDA final rule on Unique Device Identification (UDI) is expected this summer. Here are five things you need to know: 1. What is the UDI Rule? In July 2012, the FDA proposed a rule requiring medical device manufacturers to label their products with...
FDA Form 483: Top Ten Observations for Medical Devices
Medical Device manufacturers regulated by the FDA are subject to cGMP (Current Good Manufacturing Practice) regulations and may be inspected by the FDA to ensure compliance. If the FDA inspector(s) observes conditions that in their judgment may constitute violations,...
Integrating Medical Device Product Development with the Quality Management System
A critical business challenge for medical device manufacturers as they scale is getting products to market quickly while supporting existing products and meeting FDA Quality System Regulation (21-CFR-820) requirements. To achieve this effectively, Product Development...
Strategic Partners, Not Just Extra Hands
Today’s business environment requires companies to align with best-in-class vendors to be true, strategic partners. They need partners who understand their industry, their challenges, and their long-term goals. In the years we have partnered with our clients, some...
A Breakthrough in Custom Medical Implants with Creo
New medical approaches combined with innovative technologies are transforming how medical professionals treat patients. In this case study, we will explore how a young patient’s life was changed through the use of PTC Creo’s extensive capabilities. “Bioactive printed...
Navigating Compliance and Cyber Security Concerns in Smart Medical Devices
A COMPLETE OVERVIEW OF SMART MEDICAL DEVICES, THEIR DEVELOPMENT AND THEIR COMPLIANCE CONSIDERATIONS. While the Internet of Things offers great opportunities both for businesses and consumers, compliance and security must be thought through carefully from the very...
Agile Software Development and Atlassian Products (Jira, Bitbucket, Bamboo)
Unlocking the Power of Collaboration and Efficiency Tired of trying to overcome the pain points of traditional software development methods? Frustrated with slow project delivery? Struggling with team collaboration? Version control nightmares? Worry no more. You can...
Product Lifecycle Management (PLM) Automated Metrics
Our client is a leading medtech company with 46k employees. Earlier this year, they faced the challenge of improving the efficiency of their Product Lifecycle Management (PLM) process. To stay competitive, they needed to identify bottlenecks within their...
PLM: Automate your Product Development Compliance Process
Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...
How PLM Enables Innovation Without Risking Compliance
As technology has advanced, it's become more complex -- and with complexity comes the issue of tracking and monitoring the different processes and their corresponding data. In non-critical applications, the extent of this reporting is often minimal. However, in...
Accelerating Product Development with Engineering Operations
What is Engineering Operations (EngOps)? Why do you need it, and how do you effectively deploy it?There’s a strange interplay between IT and engineering teams in most firms. That’s because the tech stack that engineers need to design, build, test, and release products...