Our compliance services
Our expert team provides comprehensive regulatory and compliance services for the medical device industry, including:
- 510(k) Cybersecurity Compliance: Guiding you through the Cybersecurity requirements and guidance for the FDA clearance process for your medical device.
- EU MDR Cybersecurity Compliance: Helping you to navigate the Cybersecurity topics for your EU Medical Device Regulation submission.
- ISO 14971:2019 Compliance: Ensuring effective risk management systems for device safety.
- ISO/IEC 81001-5-1 Compliance: Supporting cybersecurity standards for medical devices.
- UL 2900-1 Compliance: Helping achieve product safety and cybersecurity certification.
Trust us to navigate complex regulations and keep your products compliant and market-ready.
