Medical Device Regulatory Support

CLEIO integrates medical device regulatory support throughout every stage of development. By building a clear understanding of applicable standards and submission pathways, we ensure each solution is compliant, well-documented, and aligned with regulatory expectations from the very beginning.

Regulatory Support Across All Medical Devices Categories

Our multidisciplinary teams develop medical technologies with regulatory compliance built in from the start, across all device classes. Medical device regulatory support ensures your product meets applicable standards and requirements while delivering safety and performance.

Connected Medical Systems

Connected devices that integrate hardware, embedded software, and data flows, ensuring alignment with system, cybersecurity, and interoperability requirements.

Medical Device Software

Software as part of medical devices, with structured architecture, traceability, and validation aligned with standards such as IEC 62304.

Therapeutic Medical Devices

Therapeutic systems with clearly defined requirements, controlled performance, and documented risk management to ensure safe and effective treatment delivery.

Diagnostic & Imaging Medical Devices

Diagnostic technologies with robust validation and documentation to support accurate data interpretation and clinical decision-making.

Drug Delivery & Combination Devices

Combination products that ensure precise dosing, safe handling, and proper integration between device and drug.

Surgical & Interventional Systems

Surgical and interventional devices with strong design control, risk management, and documentation to support precision and reliability in clinical use.

Medical Device Regulatory Support Built Into Every Stage of Development

Medical device development requires a structured process to maintain control over regulatory compliance and documentation. At CLEIO, each step aligns development activities with regulatory requirements, ensures consistency across teams, and keeps documentation complete, traceable, and ready for submission.

Regulatory Strategy Definition

We define the regulatory pathway, medical device classification, and target market requirements to guide development decisions from the start.

Documentation Framework Setup

Our team establishes a clear documentation structure, including technical files, Design History File (DHF), and traceability systems aligned with quality and regulatory expectations.

Risk Management Integration

We identify, assess, and mitigate risks throughout development in alignment with ISO 14971, ensuring safety and compliance are consistently addressed across all activities.

Traceability & Design Control

Our team connects user needs, design inputs, risk controls, and verification and validation activities to maintain full traceability and demonstrate control over the process.

Submission & Audit Preparation

We compile and review technical documentation to ensure completeness, consistency, and readiness for regulatory submissions, FDA clearance applications, and audit preparation.

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The Right Capabilities, Applied at Every Stage of Medical Device Hardware Design

Medical device hardware design and clinical equipment development require that every activity supports performance, reliability, and regulatory compliance while keeping the full system in focus. CLEIO brings together the key capabilities you need to design, test, and prepare devices for manufacturing and market entry.

Component Selection

We identify and evaluate components based on performance, availability, regulatory compliance, and long-term supply chain reliability.

PCB Development

Our electronic engineers design, layout, and iterate on printed circuit boards to ensure signal integrity, power efficiency, and seamless integration within the overall system.

Enclosure Design

We design enclosures that meet clinical environment constraints such as sterility, durability, ergonomics, and manufacturing requirements, while reflecting the intended user experience.

Bench Testing

We build and execute bench test protocols to validate electrical, mechanical, and functional performance at the component and system level.

Supplier Sourcing

We identify, evaluate, and qualify suppliers to ensure component quality, regulatory traceability, and supply chain resilience throughout development and production.

Manufacturing Preparation

Our team prepares design outputs, assembly documentation, and process validation plans to support a controlled and efficient transition to production.
CERTIFICATIONS

Quality and Compliance at Every Stage of Development

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 regulatory and development 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

Medtech Projects Showcase

Smart Patient Monitoring System with Companion App

We designed and engineered an innovative home-use patient monitoring sensor to track incontinence.

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).
TESTIMONIALS

What Our 300+ Partners Say About Us

4.6 / 5 Stars Customer Satisfaction Rating

Trusted by Industry Leaders

WHY CLEIO

Why Teams Choose CLEIO

(and Stick Around)

Ready to Step Up your Medical Device Development?

Free Access to 1:1 Consultation with Product Experts

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