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OVA Solutions

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OVA Solutions is a medical device engineering group that takes a device from the first requirement to a design your contract manufacturer can build. Our 62 engineers cover electronics, firmware, mechanics, prototyping and design transfer in one team, working under the group's ISO 13485:2016 certified quality system (certificate 044-25, held by our group company Canyon Medical Inc.).

Since 2015 we've developed 220 medical devices from Class I to Class III: wearables and remote patient monitoring, orthopedics and rehabilitation, neurotechnology and EEG, respiratory and critical care (including a ten-board portable ventilator), therapy devices, surgical robotics and hospital equipment. A typical path from idea to design for manufacturing takes 6 to 12 months.

What we do:
- Discovery: requirements, intended use, system architecture, risk inputs and a phase plan with an hours ceiling
- Electronics: low-noise analog front ends for ECG and EEG, power and battery management, BLE, Wi-Fi and cellular, multilayer and rigid-flex boards
- Firmware and embedded software on STM32, nRF, ESP32 and i.MX (FreeRTOS, Zephyr, Yocto Linux) under an IEC 62304 life cycle
- Mechanical and industrial design: enclosures, mechanisms, fluid paths, FEA, skin-contact materials, design for injection molding
- Prototyping and test rigs, with pilot and clinical batches of up to 200 units built in house
- Design for manufacturing and transfer to your contract manufacturer in the US, Europe or Asia
- Design history file, ISO 14971 risk management and technical documentation for 510(k), De Novo and PMA submissions

We design and document to IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1, ISO 14971, ISO 10993 and EU MDR 2017/745.

One published rate: $125 per hour, with the budget and timeline for each phase agreed before work starts. If something we designed doesn't work as specified, we fix it at our cost.

We work with founders building their first device and with established manufacturers who need a redesign, a firmware port or a production transfer. Offices in New York, Florida, the United Kingdom, Tallinn (Estonia) and Dnipro (Ukraine).

Company Details

Address
430 Park Avenue
New York, NY 10022

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Products & Services

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Design History File and Standards Documentation

The engineering side of a regulatory submission, built together with the device instead of reconstructed at the end. We...

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Neurotechnology and EEG Device Development

Engineering for neurotechnology: EEG acquisition boards, a wireless EEG monitoring platform, a wearable controller for...

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Respiratory and Critical Care Device Engineering

Engineering for life-support and critical care equipment. Our reference project is a portable battery-powered...

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Surgical Robotics and Hospital Equipment Engineering

Engineering for surgical robotics and operating room equipment, where precision, integration and a clean risk file...

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Medical Device Development for Startups

For founders who need a first device to show investors, run a clinical study or get to a 510(k). We start with a...

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Design for Manufacturing and Design Transfer

We make sure your device can be built. Design for manufacturing and transfer to your contract manufacturer in the US,...

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Orthopedic and Rehabilitation Device Development

Engineering for orthopedic and rehabilitation devices: load-sensing crutches, range-of-motion and gait monitors,...

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Wearable Medical Device Development

Engineering for medical and wellness wearables: wrist monitors with cuff blood pressure, skin-worn patches, glucose...

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Medical Device Prototyping and Pilot Batches

Prototypes that answer the riskiest question first, then look and behave like the production device. Digital prototypes...

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Resources & Content

Case Study: A Load-Sensing Rehabilitation Crutch, From Concept to 100 Pairs

Case Study: A Load-Sensing Rehabilitation Crutch, From Concept to 100 Pairs

How OVA Solutions built a load-sensing crutch module that helps patients follow partial weight bearing after surgery:...

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Case Study: A Single-Use Glucose Monitoring Patch for a Pharma Company

Case Study: A Single-Use Glucose Monitoring Patch for a Pharma Company

How OVA Solutions took a single-use electrochemical CGM patch with its own needle, chemistry and applicator from...

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Case Study: A Portable Ventilator Built From Ten Boards

Case Study: A Portable Ventilator Built From Ten Boards

How OVA Solutions engineered a battery-powered portable ventilator with ICU-level function at transport weight: ten...

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Categories

Industrial Design > Product R&D
Med Device Med Rect 4.30.26
11/15/23- Med Device- 3:1
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Med Device