Medical Device Development Services

Medical device development at CLEIO is an ISO 13485-certified service that delivers end-to-end design and engineering support from early concept through FDA clearance.

Your All-in-One Medical Device Development Firm

CLEIO is an all-in-one medical device development firm helping to bring a wide range of regulated products to market through integrated engineering, software, and quality expertise.

Physical Medical Devices & Equipment

End-to-end development of regulated medical hardware and clinical equipment.

Medical Software & Digital Health

Compliant medical software and digital health products built for real-world clinical workflows.

Connected & IoMT Systems

Secure, scalable connected medical ecosystems combining devices, software, and data.

Therapeutic Segments

Facing roadblocks? Need external support? Our experts will answer your questions, help you navigate challenges, and guide you through every stage of your product development journey.
EXPERTISE

Fully Integrated Expertise for Medical Device Development

Medical software development at CLEIO is led by a multidisciplinary team applying structured, compliant processes to deliver safe, market-ready solutions from concept to launch.
SOLUTIONS

Bringing a Medical Device to Market is Complex. You Don’t Have to Navigate It Alone.

Bringing a medical device to market requires coordinated expertise across human factors, industrial and UX/UI design, mechanical and electronic engineering, software development, and quality assurance. CLEIO brings together 50+ specialists working side by side within a single ISO 13485-certified quality management system to support an integrated, end-to-end path to market.

Your Challenges

Our Solutions

End-to-End Medical Device Development by CLEIO

When your product development needs to meet the industry or certification standards, IDEAL delivers the analysis, quality evaluation, and certification conformity assessment your products deserve.

Immerse

We take the time to understand the clinical problem, user needs, and market context.

Define

We clearly define the solution by aligning requirements, risks, and development objectives.

Elaborate

We design and build the solution through coordinated engineering, software, and design activities.

Adapt

We test, validate, and refine the solution to ensure performance, usability, and compliance.

Launch

We support the transition to market by preparing the product for manufacturing, regulatory submission, and commercialization.

Core Activities Across our Development Framework

CERTIFICATIONS

Built for Regulatory Approval from Day One

CLEIO structures its quality management system and product development process to align from day one with FDA, Health Canada, EU MDR, and other global regulatory requirements.

ISO 13485:2016

Quality Management System

ISO 14971:2019

Risk Management

IEC 62304:2016

Software Lifecycle for Medical Device

IEC 60601-1

Electrical Safety for Medical Electrical Equipment

IEC 62366-1

Usability Engineering for Medical Device

Quality-Driven Medical Device Development

Quality standards and certifications define how new product development is evaluated for safety, consistency, and reliability. At CLEIO, product development aligns with recognized standards that guide products from early concepts to market readiness.
CLEIO’s ISO 13485 certification means that development activities follow audited processes and comply with quality requirements. This certification demonstrates adherence to internationally recognized standards for design control, risk management, and validation.

One Team to Handle All Key Components of Medical Device Design & Engineering

Working with CLEIO means having experienced teams supporting each design and development activity, with a strong focus on compliance, traceability, and real-world use.

User Needs, Requirements & Risk Definition

We translate user, clinical, and business needs into clear, testable requirements aligned with regulatory and quality expectations.

Human-Centered Medical Device Design

Our industrial design, UX/UI, and human factors teams develop intuitive, safe, and adoption-ready solutions grounded in real-world use environments.

Multidisciplinary Medical Device Engineering

Our mechanical, electronic, firmware, and software engineers collaborate to design robust, integrated systems aligned with performance and regulatory expectations.

Prototyping & Iterative Testing

We build and refine functional prototypes to validate usability, technical performance, and subsystem integration early in development.

Regulatory Compliance & Documentation Support

We structure development activities within an ISO 13485-certified quality system, maintaining traceability and preparing compliant technical documentation.

Verification, Validation & Design Transfer

We execute structured V&V activities and support manufacturing transfer to ensure a safe, compliant, and production-ready medical device.
PROJECTS

Medtech Projects 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.

What Our 300+ Partners Say About Us

4.6 / 5 Stars Customer Satisfaction Rating

Trusted by Industry Leaders

Let's Talk About Your Medical Device Project

Free Access to 1:1 Consultation with Product Experts

Get free direct access to our senior product development experts.

Ready to get started on your project?

Our team is ready to help you think, design and engineer it.

Medical Device Development Resources Recommended for You

Explore over 100+ pieces of content to help you on your product development journey.

Common stages include research, user needs definition, concept creation, engineering, prototyping, verification, validation, and preparation for manufacturing. Each step ensures the device meets functional, regulatory, and clinical expectations.
ISO 13485, FDA regulations, and the EU Medical Device Regulation are the most recognized compliance frameworks. These certifications and rules establish requirements for quality, safety, and traceability.
A product is considered a medical device when its primary purpose relates to diagnosis, treatment, monitoring, or prevention of disease. Classification depends on intended use, level of risk, and how the product interacts with the human body.
Classification is based on intended use, duration of contact, and risk level defined by major regulatory bodies. The higher the potential risk, the stricter the classification.
ISO 13485 ensures that development activities follow a robust quality management structure. This reduces risks, improves documentation, and supports compliance with international regulations.
The process includes defining user needs, generating concepts, developing detailed designs, and testing prototypes. Verification and validation confirm that the final product meets all functional and safety requirements.
User-centered design incorporates feedback from clinicians and end users throughout the development stages. This approach improves usability, reduces risks, and leads to safer interactions in real clinical settings.
Key standards include ISO 13485 for quality management, ISO 14971 for risk management, and IEC 60601 or IEC 62304 for electrical and software safety. These standards guide design decisions and ensure regulatory readiness.