Verification & Validation for Medical Devices

CLEIO supports design verification and validation for medical devices, confirming every design requirement is met and that the final device performs safely and effectively in real-world conditions. Our structured approach ensures full traceability and regulatory compliance, so your path to submission and manufacturing is clear.

Our Structured Process for Medical Device Verification and Validation

Medical device verification and validation must follow a structured process to ensure every design output is tested against its intended requirements. CLEIO applies a disciplined, end-to-end process that builds compliance and traceability into every phase, from planning through regulatory submission.

V&V Planning

We define the verification and validation strategy, establish acceptance criteria, and allocate resources and responsibilities, aligned with design controls and regulatory requirements.

Requirements Mapping

Our team builds a requirements matrix linking user needs and design inputs to design outputs and test cases, ensuring complete, verifiable coverage that meets regulatory and clinical specifications.

Protocol Development

We document detailed test methods, procedures, and acceptance criteria for each design output, including performance and safety protocols, with formal review and approval completed before test execution begins.

V&V Execution

We perform verification and validation activities according to approved protocols, documenting all results, deviations, and conclusions in formal test reports.

Documentation

Our team consolidates all V&V documentation into a complete, audit-ready design history file (DHF) with the evidence and traceability needed to support your FDA or regulatory submission.

What Activities Are Included in Medical Device Verification and Validation Services?

Medical device verification and validation services rely on a coordinated set of activities, each contributing to a complete and audit-ready V&V record. Our integrated multidisciplinary team brings the expertise to execute every activity rigorously and efficiently.

Design Reviews

We conduct formal design reviews at key development milestones to confirm requirements are met, risks are addressed, and the design is ready to progress.

Risk Management

Our team identifies, analyzes, and mitigates design-related hazards throughout the V&V process in accordance with ISO 14971, ensuring risk controls are integrated with verification activities.

Bench and Functional Testing

We verify mechanical, electronic, and software performance against design specifications under controlled laboratory conditions, documenting all results and deviations in formal test reports.

Biocompatibility and Environment Testing

Our team assesses material safety and device performance under relevant environmental conditions, aligned with ISO 10993 and applicable regulatory standards.

Usability Testing

We conduct formative and summative usability studies with representative users to validate safe and effective device interaction under intended use conditions, aligned with IEC 62366 and FDA guidance.

Software Verification

Our team performs structured testing of embedded software functionality, performance, and safety against software requirements in accordance with IEC 62304.
CERTIFICATIONS

Quality and Compliance Standards Guide Medical Device Verification and Validation

CLEIO applies an integrated quality management system built on internationally recognized medical device standards. From concept through market launch, our multidisciplinary teams collaborate within a controlled ISO framework to ensure all development activities meet quality assurance best practices.
ISO 13485 certification ensures that all verification and validation work is guided by audited, structured processes that support consistent service quality and reliable outcomes. Products are developed in accordance with applicable harmonized standards to meet medical device regulatory requirements, accelerating time to market and supporting approval by relevant authorities.

ISO 13485:2016

Quality Management System

ISO 14971:2019

IEC 62304:2006 / AMD1:2015

IEC 60601-1 Ed. 3.2

IEC 62366-1:2015 / AMD1:2020

PROJECTS

Medical Device Design Showcase

Explore medical innovations we’ve worked on.

Revolutionary Oncology Medical Device to Treat Cancer

Our largest project yet. We designed and engineered the Polartrak, a proprietary and revolutionary medical device developed by Starpax Biopharma to treat cancer.

Console for Calcified Artery Disease Treatment

We have collaborated with Soundbite Medical to design and develop the latest commercial version of their medical device.

Ophthalmology Device with Software Driven by AI

Development of an ophthalmology diagnostic tool using offline image analysis software driven by artificial intelligence (AI).

Smart Patient Monitoring System with Companion App

Design and engineering of an innovative home-use patient monitoring sensor to track incontinence.

WHY CLEIO

Why Teams Choose CLEIO

(and Stick Around)

CLEIO is a medical device development firm that brings together mechanical, electronic, firmware, human factors, and systems engineering expertise within a single ISO 13485-certified organization. Our integrated approach makes us a natural partner for verification and validation services, where quality and compliance depend on coordinated work.
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