Take Control of Medical Device Regulatory Compliance
Meet global regulatory requirements, automate supplier data collection, assess supplier compliance in real-time, and generate audit-ready documentation — all in one medical device compliance management platform.
Stop Letting Regulatory Complexity Slow You Down
Medical device manufacturers face mounting regulatory pressure. New and evolving standards demand deeper material transparency, stronger supplier oversight, supplier compliance management, and complete documentation.
Manual tracking and disconnected systems put your business at risk.
- Struggling to collect complete supplier compliance data?
- Preparing for audits with scattered documentation?
- Navigating REACH, RoHS, EU MDR, and emerging standards?
- Losing time to manual processes and data gaps?

Take A Tour Of Our Medical Device Compliance Solution
Whether you’re responding to PFAS and restricted substance inquiries, managing human rights expectations, designing for EU MDR compliance, or preparing for audits, Source Intelligence offers a flexible medical device compliance management platform to fit your business priorities.
What Our Customers Are Saying
Technology, visibility, supplier compliance management, and trusted guidance — an all in one solution that isn't just EU MDR compliance software. Real stories from customers who’ve transformed compliance with Source Intelligence.
Material Program Manager
Aerospace & Defense Manufacturer
“ Subject matter experts. User-friendly portal. Easy communication. On-time reporting. ”
Environmental Compliance Manager
Automation Machinery Manufacturer
“ Gathering data manually within our organization was extremely time-consuming and expensive. SI gathered about 60% of our data in four months... more than we gathered over the course of five years! ”
Senior Director of Supply Chain
Biotech Research Company
“ This tool pays for itself — many times over! ”
Material Program Manager
Aerospace & Defense Manufacturer
“ Subject matter experts. User-friendly portal. Easy communication. On-time reporting. ”
Environmental Compliance Manager
Automation Machinery Manufacturer
“ Gathering data manually within our organization was extremely time-consuming and expensive. SI gathered about 60% of our data in four months... more than we gathered over the course of five years! ”
Senior Director of Supply Chain
Biotech Research Company
“ This tool pays for itself — many times over! ”
Simplify Medical Device Supply Chain Compliance With One Connected Platform
Source Intelligence helps you centralize compliance data, automate supplier engagement, and confidently meet medical device supply chain compliance requirements. Replace spreadsheets and reactive workflows with a scalable system designed for medical device manufacturing compliance.
Reduce
internal burdens
Collect full material disclosures and regulatory declarations faster — with built-in validation.
Identify compliance gaps instantly
Use AI-enhanced insights to flag risks before they become audit findings.
Generate audit-ready documentation
Produce compliance reports and certifications in minutes instead of days or weeks.
Integrate with existing systems
Connect seamlessly to PLM, ERP, and quality systems without disrupting operations.
Seamless integration with your existing systems
Our medical device compliance software is designed with connectivity in mind. We offer data integration to all major PLM and ERP platforms with the flexibility to scope out and connect with systems outside our current connectors.
Comprehensive Medical Device Regulatory Compliance Software
Strengthen your supply chain from end to end with our configurable suite of AI-powered compliance and sustainability software solutions. Developed to keep you steps ahead of regulatory changes, our software is backed by robust technology and experts with a diverse background of regulatory experience. This is medical device industry compliance — built for scale and complexity.
Product compliance
Identify risks to ensure every supplier, part, and product meets core compliance obligations. Regulations we cover include Global REACH, Global RoHS, EU MDR, PFAS, and more.
Responsible sourcing
Uncover exposure to your suppliers engaged in conflict minerals sourcing, deforestation (EUDR), human rights violations, and other areas of concern with our compliance management platform.
Sustainability
Comply with the increasing number of sustainability policies and escalating consumer demands, including Extended Producer Responsibility packaging legislation, WEEE, and EU Batteries.
Parts obsolescence
Avoid unnecessary production delays by receiving early warning of parts at risk of obsolescence with plenty of time to identify replacements with our medical device regulatory compliance software.
