Are you a medical device manufacturer seeking to overcome the challenges of your current quality management? Let me help you show you the light. In this blog, we will show you the advantages of adopting an Enterprise Quality Management System (eQMS). Better yet, one...
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...
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...
Medical device companies face complex quality management challenges and strict regulatory requirements. An electronic quality management system (eQMS) like Greenlight Guru, can help companies ensure compliance, improve efficiency, facilitate collaboration, and scale...
The Neuromodulation department of Medtronic is a global leader in medical technology. Recently, they implemented codeBeamer ALM to overcome issues. These were issues that their previous software ecosystem wasn’t able to efficiently address. The organization aimed to...
In April 2022, PTC acquired Intland Software, the maker of CodeBeamer and CodeBeamer X. Codebeamer is an excellent tool for global leaders and innovators in regulated industries like Medical Devices. Its core purpose is to simplify product engineering and assist in...
Medical devices are subject to some of the strictest design controls and regulations in the world. And for good reason. U.S. medical devices are governed by the Food and Drug Administration (FDA). In order to meet the high standards, teams must communicate -...
Our client is Fortune 100 Medical Device manufacturer. SPKAA acts as a product cybersecurity managed service provider for their hospital products which have embedded Windows or Windows OS. Fortune 100 MedDevice Problem For over 10 years, SPK has provided ongoing...
What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device. SaMD devices also need to meet the...
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...
Accelerating Product Development to Improve Patient Outcomes SPK and Associates, a leading woman-owned technology consulting company, today announced its partnership with Greenlight Guru, pioneer of the only dedicated Medical Device Success Platform (MDSP) to...
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...