Medical Device Engineering
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...
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...
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...
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...
How a Leading Medical Device Company Enhanced Collaboration by Migrating from Jira and Confluence Server to Cloud
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...
How Medical Device Engineers Can Streamline CAD Workflows for Faster FDA Approval
Balancing speed and compliance in medical device engineering can be challenging. Engineers face tight deadlines and detailed requirements to bring life-saving products to market. Your CAD workflows should aid in the path to compliance and accelerate FDA approval. As...
Accelerating Product Development the SPK Way
Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...
ROHS 2 for Medical Devices: Are You Ready?
As of July 22, 2014, the RoHS (Restriction of Hazardous Substances) Directive must be observed for first time distribution of all medical devices to the full extent. Furthermore, all products with a CE marking must also be RoHS-compliant. ROHS 2 Compliance Changes at...