Regulatory Guidance

What we can do

✅ Define Your Regulatory Strategy

Tap into deep medtech expertise to craft regulatory strategies that ensure global compliance and accelerate market access.

📋 Quality Management Systems

Implement ISO 13485, CFR 21, or MDSAP-ready QMS tailored to your operations—built for compliance, driven by excellence.

📄 Technical Documentation

We prepare and submit CE, FDA, and other market-specific technical files with precision and regulatory insight.

🔍 Audits & Supplier Oversight

Thorough audits of subcontractors and suppliers to reduce risk and maintain top-tier quality across your value chain.

🧪 Validation Services

Comprehensive validation of processes, systems, and software to meet regulatory expectations and ensure reliability.

🌍 Market Expansion

Enter new markets confidently with compliant documentation and local regulatory alignment.

🔄 Pre & Post-Market Support

From lab testing to PMS and PSURs, we support your full product lifecycle under standards like IEC 60601.

⚠️ Risk Management

Proactive ISO 14971-based risk assessments to safeguard product safety and long-term success.

Contact Us

Reach out for expert guidance on medical device regulations and digital health compliance. We're here to help navigate your regulatory challenges.

Inquiry

contact@webthreehealth.com