Prototyping & Iterative Testing for Medical Devices

CLEIO supports medical device prototyping and testing. From early proof-of-concept to design verification, our approach ensures each prototype iteration strengthens performance, usability, and readiness for the next stage of development.

Prototyping and Testing for Complex Medical Device & Healthcare Technologies

Our multidisciplinary teams develop and test complex medical technologies for healthcare companies, medical device manufacturers, and innovative startups, ensuring performance, usability, and compliance at every stage.

Connected Medical Systems

Connected medical technologies that integrate hardware, embedded software, and data communication.

Medical Device Software

Medical device software with functions, user interfaces, and system interactions built to ensure performance, usability, and compliance.

Therapeutic Medical Devices

Therapeutic systems that ensure safe, consistent, and controlled treatment delivery.

Diagnostic & Imaging Medical Devices

Diagnostic technologies that support accurate data acquisition and reliable clinical decision-making.

Drug Delivery & Combination Devices

Solutions designed for precise dosing, reliable administration, and safe interaction between device and drug.

Surgical & Interventional Systems

Devices built for precision, reliability, and ease of use in demanding clinical environments.

Our Key Capabilities for Effective Prototyping and Iterative Testing

Medical device prototyping and iterative testing deliver better outcomes when rapid execution is paired with controlled documentation and disciplined iteration. At CLEIO, we ensure each prototype has a clear purpose, each iteration remains traceable, and each test brings validation for the next stage.

Rapid Prototyping

We develop functional and physical prototypes using appropriate tools, technologies, and fabrication methods.

Change Management & Traceability

We document each prototype, test, and iteration to maintain traceability and prevent delays due to incomplete documentation.

Risk Management

We identify, assess, and mitigate technical and use-related risks at every stage of prototyping and testing.

Real-Word Condition Testing

We simulate clinical environments to evaluate performance, usability, and constraints such as space, sterility, and user behaviour through formative evaluations.

Cross-Disciplinary Integration

We ensure close collaboration between design and engineering, with each discipline clearly communicating its requirements and constraints.

Prototyping Method Selection

We choose the most appropriate prototyping methods (3D printing, plastic injection molding, CNC machining, interactive prototyping) to accurately represent device functionality.
CERTIFICATIONS

Quality Management and Regulatory Alignment Across Medical Device Development

CLEIO applies an integrated quality management system built on internationally recognized medical device standards, ensuring multidisciplinary development activities follow quality assurance best practices.
ISO 13485 certification ensures that all development work is guided by audited, structured processes that support consistent service quality and reliable outcomes. In parallel, 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)

TESTIMONIALS

What Our 300+ Partners Say About Us

4.6 / 5 Stars Customer Satisfaction Rating

Let's Talk About Your Medical Device Project

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