Accelerating 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. The program required strong regulatory consulting for medical devices to align product development, testing, documentation, and submission readiness under a compressed timeline.

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 testing 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 with ISO 13485 quality system practices alignment
Integrated testing of the product, including multi-RF coexistence tests at TUV labs
Pre-sub and supplemental submission discussion with FDA reviewers to reduce review cycles and improve the FDA 510(k) submission timeline

iOrbit Scope

A new and quite novel patient monitoring device using wireless sensors, with a very limited number of predicate devices, was 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, requiring HF test reports.
Cloud-connected data in a secure way with wireless data communication, requiring full adherence to cybersecurity requirements and wireless coexistence testing.
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 with structured medical device regulatory expertise support.

Key Outcomes

FDA 510(k) K243837 obtained within 120 days of submission with no repetitive responses.

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