Regulatory Compliance Associates (RCA), a Nelson Labs company, along with Sterigenics and Nelson Labs, part of Sotera Health, offer an integrated suite of services tailored for wearable and implantable connected medical devices. From concept to commercialization, they help navigate complex regulatory landscapes, ensuring quality, safety, and speed to market.

Why Choose Us?

• Expert Guidance: Advisory services covering design, regulatory strategy, software development (including SaMD), cybersecurity, and risk management.
• Advanced Testing: Material compatibility, biocompatibility, battery performance, microbial testing, and more.
• Sterilization Excellence: Full-spectrum sterilization technologies including Gamma, EO, E-Beam, X-Ray, and Nitrogen Dioxide, with global GMP-certified facilities.
• Global Reach: Serving over 5,000 customers across 62 facilities in 13 countries.

Integrated Ecosystem for Connected Care

RCA, Sterigenics, and Nelson Labs support the entire connected device lifecycle, ensuring seamless integration with electronic health records and AI-driven care platforms.

Learn how RCA, Sterigenics, and Nelson Labs can accelerate your connected medical device project with unmatched expertise and global capabilities.