OVA Solutions does its engineering work under a quality management system certified to ISO 13485:2016. This page gives the certificate details, explains which company holds it, and says what the certificate covers and what it does not.
Certificate details
| Standard | ISO 13485:2016 (EN ISO 13485:2016, DSTU EN ISO 13485:2018) |
|---|---|
| Certificate number | 044-25 |
| Certificate holder | Canyon Medical Inc., 254 Chapman Rd, Ste 209, Newark, DE 19702, USA |
| Scope | Design and development, production and distribution of medical device prototypes |
| Certification body | Improve Medical LLC, Kyiv, Ukraine |
| Valid | October 14, 2025 to October 13, 2028 |
A copy of the certificate is available on request: info@ovasolutions.com.
Which company holds the certificate
OVA Solutions is the brand of a medical device engineering group. In the United States we work through Canyon Medical Inc. and OVA Solutions LLC, both Delaware companies. In the European Union we work through Alnicko Lab OÜ in Tallinn, Estonia. All engineering is done by one team of 62 engineers. The certificate is held by Canyon Medical Inc., and the group’s engineering work runs under that quality system.
What the certificate covers
- How we plan a design project and record requirements.
- How we review, verify and document the design at each stage.
- How we control changes, suppliers and prototype builds.
What it does not mean
- It is not an FDA clearance or approval of any device. Each device goes through its own regulatory path.
- It is not an FDA certificate. FDA does not issue or require ISO 13485 certificates, and a certificate does not exempt a manufacturer from FDA inspection.
- It does not make us the manufacturer of your device. Your company stays the legal manufacturer and owns the regulatory submission.
- The scope covers prototypes. Volume production is done by contract manufacturers, and we support the transfer to them.
Why ISO 13485 matters more since February 2026
On February 2, 2026 the FDA Quality Management System Regulation took effect. It incorporates ISO 13485:2016 by reference into 21 CFR Part 820. In practice this means that design records built to ISO 13485 follow the same structure FDA now expects from a device manufacturer’s design and development process. Source: FDA, Quality Management System Regulation.
What you receive from a project
- Schematics and PCB design files, including Gerber files.
- Firmware.
- Mechanical CAD.
- Test reports.
- Design history file records for the work we did.
What OVA does here, and where our responsibility ends
We are a full-cycle hardware engineering team: electronics, firmware, mechanics, prototypes, design for manufacturing, transfer to production and production support. We analyze the regulatory path and prepare design documentation. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission belong to you or your regulatory consultant, and production is done by manufacturing partners.
Common questions
Is OVA Solutions ISO 13485 certified?
OVA Solutions works under an ISO 13485:2016 certified quality management system. The certificate, No. 044-25, is held by Canyon Medical Inc., a company of the same group, and is valid until October 13, 2028.
Who issued the certificate?
Improve Medical LLC, a certification body in Kyiv, Ukraine.
Does the certificate cover manufacturing?
The scope is design and development, production and distribution of medical device prototypes. Volume manufacturing is done by contract manufacturers.
Does ISO 13485 certification mean a device is FDA cleared?
No. Certification describes how a company works. Clearance or approval is a decision FDA makes about one specific device.
Sources: FDA, Quality Management System Regulation · FDA, QMSR frequently asked questions
Updated on October 7, 2026.