At RA360, we make design controls work for you. We turn complex regulatory requirements into practical processes that streamline development while ensuring compliance with ISO 13485 and 21 CFR 820.30.

We provide comprehensive support for EU MDR and IVDR compliance, helping you navigate the complex European regulatory landscape effectively.

We provide comprehensive support for medical device clinical data requirements in compliance with EU MDR and applicable guidelines. Our approach covers the complete spectrum of clinical evidence needs.

V&V activities and compliance with international standards are the foundation of device excellence. Our verification, validation, and standards compliance expertise transforms complex requirements into streamlined testing strategies that prove your device works as intended and meets global safety benchmarks and regulatory requirements.

Effective risk management creates fundamentally safer medical devices. Implementation of ISO 14971 requirements is not only mandatory but also helps you identify and address risks at their source, protecting users and strengthening your regulatory position.

Training

From Understanding to Confidence
Regulatory knowledge isn't just about facts—it's about empowering your team to make informed decisions with confidence. Our training programs create understanding that transforms compliance from a burden into a natural part of your development process.

We offer specialized guidance in developing and maintaining Quality Management Systems aligned with ISO 13485, FDA 21 CFR part 820 (QSR/QMSR),  MDSAP, and EU MDR requirements, transforming regulatory obligations into operational advantages.