In today’s rapidly evolving MedTech landscape, maintaining compliance while accelerating innovation is more challenging than ever. At Stefanini, we offer a comprehensive suite of Quality and Regulatory Assurance services designed to help you navigate complex regulatory requirements, mitigate risk, and bring safe, compliant products to market — faster and smarter.
Whether you’re preparing a 510(k) submission, implementing a Quality Management System (QMS) aligned with QSR or ISO standards, or validating your software and digital infrastructure in accordance with FDA and global data privacy regulations, our global team of experts is here to guide you every step of the way.
We combine deep regulatory knowledge with hands-on industry experience to provide tailored solutions across the entire product lifecycle — from design and documentation to risk analysis and regulatory submission.
What You’ll Discover in the Brochure:
- Regulatory submission support (510(k), CE Marking)
- IEC 60601-1 and IEC 62304 compliance
- QMS implementation & audit readiness
- CAPA, DHF gap analysis, SOP development
- ISO 14971-compliant risk management
- FDA 21 CFR Part 11 and software validation
- Data privacy compliance (US/EU)
Why Stefanini?
✔ Holistic, end-to-end regulatory services
✔ Deep global expertise across regions
✔ Proven compliance across MedTech domains
✔ Scalable, customized solutions tailored to your needs
Ready to Ensure Compliance and Drive Quality Excellence?
Download our detailed brochure and discover how Stefanini can support your journey to safer, smarter, and fully compliant medical innovations.