Unlock the secrets to seamless FDA compliance with our comprehensive eBook. This practical guide breaks down the regulations and standards that matter most, including 21 CFR Part 11 and Part 820, and walks you step-by-step through risk-based validation, robust...
Medical Device Engineering
Agile Development in Regulated Environments – Part 1: Yes, it can work
The value system and practices that embody Agile Software Development have been around for well over a decade, and have been touted as having "crossed the chasm" by organizations such as the Agile Alliance, Gartner, and Forrester Research. Numerous studies indicate...
How to Achieve Compliance with FDA 21 CFR Part 11 for Electronic Records and Signatures
In highly regulated industries like medical devices, maintaining data integrity and regulatory compliance is non-negotiable. One of the key regulations in this space is FDA 21 CFR Part 11, which governs the use of electronic records and electronic signatures. It...
Strategies to Overcome the Top Challenges in Medical Device Manufacturing
Medical device manufacturing is one of the most regulated, complex, and high-stakes industries in the world. From ensuring compliance with evolving global regulations to protecting patient data, companies face a multitude of hurdles. These are just what is expected....
Your PLM, The Cloud, and FDA Regulation: What You Need to Know
Product designs, documentation, and processes aren’t just valuable intellectual property, they’re your license to operate. In the highly regulated medical device industry, manufacturers must carefully consider these factors. If you’re using a Product Lifecycle...
Navigating the EU MDR Transition: What Medical Device Companies Need to Know
The EU Medical Device Regulation (EU MDR) transition is a significant regulatory shift that medical device companies must take seriously. Replacing the previous Medical Device Directive (MDD), the EU MDR (Regulation (EU) 2017/745) introduces more stringent...
How Cloud-Based CAD Is Changing the Future of Collaborative Design
Traditional desktop-based CAD tools, while powerful, can have a hard time meeting the growing demands of modern engineering teams. They need better connectivity, scalability, and flexibility. That’s why cloud-based CAD (Computer-Aided Design) is quickly becoming the...
Navigating Tariffs: How SPK’s Expertise Can Lead to Enhanced Automation in U.S. Medical Device Manufacturing
Tariffs have long been a tool of economic strategy, but recent escalations are impacting U.S. manufacturers, especially in the medical device industry. From 10% baseline tariffs to 245% duties on Chinese imports, companies now face inflated costs and disrupted global...
3 Top Trends in Product Lifecycle Engineering Tools
Overview In 2015, SPK and Associates co-founder Chris McHale spoke with Peter Thorne, Director at Cambashi, a Cambridge, England-based independent industry analyst firm. With his over 30 years of experience as a software engineer user, vendor, and now analyst, Peter’s...
Nationwide Upgrade of Critical Medical Devices for Enhanced Hospital Operations
Medical device manufacturers know how rapidly technologies can change in the field. Ensuring you provide hospitals with innovative tools that meet regulatory requirements is vital. When a leading medical device manufacturer needed help upgrading software and hardware...
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...
How SPK’s Application Management Services Optimized Licensing Costs and Enhanced Tool Utilization
Licensing costs can be expensive, especially when you have large teams utilizing multiple tools. In the case of one of our clients, a medical equipment supplier, they were spending thousands of dollars on dozens of tools. Luckily, with the help of SPK as their...