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...
Achieving compliance with ISO 9001 requires making quality and version control a priority. This eBook explores our experts’ ten best practices for ensuring ISO 9001 compliance.What You Will Learn Discover tips for achieving ISO 9001 certification such as: Establish a...
With constant pressure to deliver high-quality products, Model-Based Definition (MBD) has emerged as a game-changer. MBD is particularly useful for companies aiming to achieve precision manufacturing and meet compliance regulations. By using MBD in CAD, manufacturers...
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...
Regulated industries face immense complexity in designing, producing, and maintaining high-quality products. Balancing this while ensuring compliance, managing data, and accelerating innovation is not possible without the proper tools. That’s why Product Lifecycle...
As software-driven complexity grows across industries like automotive and medical devices, engineering teams are facing unprecedented challenges—from ensuring regulatory compliance to accelerating time to market while maintaining high software quality and safety...
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...
Hi everyone, I am Daniela, and I am the CAD SME for SPK and Associates. Today we'll be discussing version control in CAD. Why Version Control in CAD Matters Version control in CAD is mission-critical for maintaining your CAD resources. It really ensures stability,...
As complex, smart, and connected products become the norm, manufacturers must contend with increasingly stringent regulations. Traceability and compliance are mission-critical. Manufacturers must also meet rising customer expectations and overcome unpredictable supply...
Protecting documentation inside project tools like Jira Cloud can be a challenge in regulated environments. Whether you're managing technical files, contracts, or quality compliance records, attachments are often scattered and exposed to unnecessary users....
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...
Digital disruptions such as cyberattacks or system failures are one of the largest threats to the financial sector. Recognizing the increasing reliance on digital infrastructure, the European Union introduced the Digital Operational Resilience Act (DORA). This act...