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....
Edwin Chung
Lessons Learned in Overcoming Digital Thread Challenges
The digital thread is a transformative approach to connecting data, systems, and teams across the product lifecycle. It enables seamless access to real-time data and traceability across departments and tools. However, for many organizations, implementing a robust...
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...
Why Every Engineering Team Needs a Strong PDM Strategy
Welcome to Why Every Engineering Team Needs a Strong PDM Strategy Hey everyone and welcome back to our vlog series where we talk about all things engineering, IT, and innovation. I'm Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates....
6 Questions to Ask Your CAD/PLM Software Vendor
When you’re a discrete manufacturer, your product designs and data are the crown jewels of your business. They define your intellectual property, drive your revenue, and differentiate you from the competition. Entrusting that IP to a CAD or PLM software vendor is a...
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...
Navigating Tariffs: How SPK’s Expertise Can Lead to Enhanced Automation in U.S. Automotive Manufacturing
As new tariffs are enacted upon vehicles, auto parts, and raw materials, U.S. automotive manufacturers are facing new challenges. Escalating costs, disrupted supply chains, and uncertain trade policy are among these. While OEMs scramble to mitigate the impact, one...
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...
Managing Enterprise Change to Mitigate Risks and Maximize ROI
Whether you are implementing technological advancements or strategic business initiatives, enterprise-level change within your organization is inevitable. The ability to effectively manage this change separates successful organizations from those that struggle. ...
Best Practices for Product Engineering Teams to Reduce Quality Costs
Cutting down quality-related costs without compromising product performance can be a difficult balancing act. Improving efficiency, eliminating waste, and ensuring compliance can all exist in tandem when engineering teams implement best practices. Utilizing defect...
Analytics and AI That Matter In Product Development
The integration of data, AI, and analytics is transforming the workflows of product development companies. With AI-driven insights, businesses can streamline their design, development, and launch processes while mitigating risks. In this blog, our team wanted to...
Engineering Excellence: Real Results, Not Just Resources
Engineering Excellence Hello and welcome to Engineering Excellence: Real Results, Not Just Resources. My name is Michael Roberts, Vice President of SPK and Associates, and I'm here with Edwin Chung. Ed, feel free to introduce yourself. Hey, please call me Ed. I'm VP...