This knowledge base distills lessons from years of engineering in regulated environments - shared openly so you can learn, challenge, and build better, faster.
We believe expertise is worth nothing if it’s hoarded. This space is where we break down our tools, processes, and design thinking - not to impress, but to empower. Whether you’re validating a medical device or improving production yield, our knowledge base is here to help you move faster, avoid pitfalls, and meet the standards that matter. If something we’ve learned can save you a step or spark an idea, we’ve done our job.
Bringing a regulated product to market requires more than just engineering - it demands a structured, traceable development process that meets industry standards. The steps below reflect a framework based on key quality and regulatory requirements, including ISO 13485 (medical device QMS), ISO 14971 (risk management), 21 CFR Part 820 (FDA design controls), and GAMP 5 (validation for automated systems).
Click each stage below, to learn more about the essential activities and documents used to ensure product quality, reduce risk, and maintain compliance from concept through to post-market control.
This section includes practical tools to support your development and automation projects. All resources are free to use and designed to help with planning, justification, and documentation.
If you’re reviewing a new process, preparing a product for development, building a business case for investment, or simply just want to learn - click each stage below.
