Enabling Smarter Healthcare with Vendor-Agnostic Interoperability
October 28, 2025Enabling Smarter Healthcare with Vendor-Agnostic Interoperability
October 28, 2025Accelerating FDA Clearance Through Smart, Cost-Effective Regulatory Planning & Implementation
About Client
A globally recognized leader in patient monitoring systems, now expanding into the wireless monitoring segment with next-generation products designed for the US market..
Client’s Challenge
The client sought to achieve FDA and EU regulatory compliance for a new wireless patient monitoring system but was constrained by limited in-house regulatory and engineering capacity during the NPD phase.
iOrbit Solution
- Detailed device study and product classification as Class II device
- Predicate device study and Substantial Equivalence analysis
- Full Product Usability Engineering File with URRA (Use related risk assessment) , along with Safety and Security Risk management completion
- Key performance criteria determination and tests
- Software architecture, design, unit tests and verification
- Third party cybersecurity tests completion
- Wireless coexistence tests completion
- All consensus standards test completion
- Detailed device description and information as part of submission deck
- Complete bench test reports and analysis reports
- HF validation test plan and reports
- DHF, IFU labelling and Medical Device File readiness for submission leveraging the iOrbit 13485 processes
- Integrated testing of the product, including multi-RF coexistence tests at TUV labs
- Pre-sub and supplemental submission discussion with FDA reviewers
iOrbit Scope
- A new and quite novel patient monitoring device using wireless sensors, with a very limited number of predicate devices, is required to get regulatory clearance for market access in the US region.
- Large number of physiological parameters and functions to be monitored in real-time.
- Multiple product codes are applicable.
- Very elaborate intended use and indications of use
- Enhanced usability requirements for the device, need HF test reports
- Cloud connect data in a secure way, wireless data communication, Need full adherence to cybersecurity requirements and wireless coexistence tests
- FDA certification mandatory and future CE certification requirement
- Complete Product DHF, Cybersecurity and Safety and Security Risk Management, Usability study, HF validation study
- Comply with all applicable Consensus standards and cybersecurity requirements.
Key Outcomes
FDA 510(k) K243837 obtained within 120 days of submission with no repetitive responses.