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Quality, Risk & Regulatory Management

CLEIO is an ISO 13485-certified design and development partner for regulated products. Integrated quality, risk, and regulatory management processes ensure product safety, reliability, and compliance from concept through commercialization.
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Regulated Product Development Across Physical, Digital, and Connected Products

CLEIO applies a unified regulated product development framework to physical hardware, software applications, IoT systems, and medical devices, ensuring consistent quality and compliance across every product category.

Medical Devices

Medical device development under ISO 13485 for products that must meet clinical, regulatory, and commercial requirements.

Physical Products

Regulated development of physical hardware, including industrial equipment, consumer devices, and specialized mechanical systems.

Software & Apps

Software and application development aligned with regulatory standards, built for reliable performance in real-world clinical and commercial use.

Connected & IoT Systems

Connected product development integrating hardware, embedded software, and data systems for secure, compliant performance.

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

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EXPERTISE

A Development Process Built on Design Controls for Regulated Products

Design controls for regulated products structure every phase of CLEIO’s IDEAL development process, from concept through market release. Each stage integrates quality management, risk analysis, and documentation to produce production-ready products with complete regulatory traceability.

Core Activities

  • Quality Management & Planning
  • Risk Management
  • Design Controls
  • Design Verification Testing
  • Change Management
  • Document Control
  • Manufacturing Transfer & Support
  • Regulatory Compliance (US, CAN, EU)
  • Standards Analysis
  • Design History File (DHF)
  • Design HistoryDevice Master Records (DMR)File (DHF)

Quality-Driven Guidance Through Every Design and Development Activity

Partnering with CLEIO gives you expert guidance in planning design and development activities, ensuring alignment with industry standards and regulatory requirements.

Planning and Defining Requirements

We ensure that each stage of design and development is planned with defined inputs, outputs, and acceptance criteria to meet applicable quality and regulatory standards.

Documentation Management

We apply structured documentation practices to ensure that all design records, test reports, and regulatory files are accurate, comprehensive, and ready for audit.

Risk Management

We conduct risk identification using FMEA and structured hazard analysis to implement effective mitigation strategies that prevent costly redesigns and regulatory approval delays.

Design Verification

We perform comprehensive design verification, including functional testing, design reviews, and requirements traceability, to confirm that the final product performs as intended.

Regulatory Strategy Support

We provide strategic regulatory guidance to ensure product design and development aligns with applicable local and international standards across target markets.

Timeline Estimation

We define accurate estimates of effort and timelines for each development activity to enable reliable schedule forecasting and keep regulated product programs on track and within scope.
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SOLUTIONS

Quality and Compliance, Built Into Every Stage

Regulatory compliance in product design is a continuous effort, not a final checkpoint. CLEIO integrates quality and regulatory processes at every development stage so products are safe, compliant, and reliable from the first design decision.

Your Challenges

  • Unresolved product performance issues and safety risks identified late in development.
  • Regulatory requirements that vary across jurisdictions and evolve with new standards.
  • Late-stage compliance gaps that delay market approvals and extend project timelines.
  • Inconsistent manufacturing output caused by undefined quality controls.
  • Insufficient documentation that weakens stakeholder confidence and complicates funding.

Our Solutions

  • ISO 13485-aligned quality management that standardizes manufacturing processes.
  • Structured design controls that verify product safety and eliminate defects before production.
  • Regulatory strategy integrated from concept phase to align with applicable standards.
  • Early-phase risk identification that prevents costly rework and accelerates time-to-market.
  • Comprehensive quality documentation that builds measurable confidence with investors, partners, and regulators.
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.
PROJECTS

The Latest Certified Products We’ve Brought to Market

From life-saving MedTech innovations to cutting-edge digital solutions, explore our latest projects.
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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.

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Console for Calcified Artery Disease Treatment

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

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Ophthalmology Device with Software Driven by AI

Development of an ophthalmology diagnostic tool using offline image analysis software driven by artificial intelligence (AI).
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Smart Patient Monitoring System with Companion App

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

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What Our 300+ Partners Say About Us

4.6 / 5 Stars Customer Satisfaction Rating

Trusted by Industry Leaders

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Free Access to 1:1 Consultation with Product Experts

Get free direct access to our senior product development experts.

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QA & Regulatory Compliance Resources Recommended for You

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

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A Step-by-Step Guide to Usability Engineering in Medical Device Development

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Elevating User Safety in Medical Devices with IEC 62366-1 and Related Standards

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How Usability Brings Value to Risk Control in Medical Device Design

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Frequently Asked Questions About Quality, Risk & Regulatory Management

Design verification confirms that design outputs meet the predefined design inputs through controlled tests and inspections. Design validation ensures the final product satisfies user needs and intended use under actual or simulated conditions.
A QMS enforces structured procedures such as design controls, risk analyses, and document traceability required for higher-risk device categories. It also ensures evidence-based compliance with regulatory frameworks like 21 CFR 820 and EU MDR.
Risk analysis identifies latent hazards, fault modes, and potential misuse scenarios before design decisions are finalized. This enables preventive mitigations that reduce downstream redesigns and regulatory friction.
GDP defines rules for creating legible, accurate, and audit-ready records such as protocols, logs, and technical files. These practices ensure data integrity and support regulatory inspections without rework.
QA prepares device master records, assembly instructions, and inspection criteria needed for repeatable production. It also conducts process verifications to ensure that suppliers and assemblers can replicate the intended quality level.
A DHF compiles all records demonstrating that design controls were applied throughout development. It serves as formal proof of compliance for regulatory submissions and audits.
QA maintains centralized versioning, review workflows, and approval logs to prevent conflicting or outdated documents. This ensures that engineering, design, and manufacturing teams operate using synchronized information.
Process validation demonstrates that a production process reliably produces items that meet specifications. It is required when output quality cannot be fully verified through end-of-line inspection alone.
QA enforces security requirements such as device authentication, secure boot, and encrypted communication. It also documents threat modeling and vulnerability mitigations aligned with FDA cybersecurity guidance.
Documentation includes software requirements, architecture files, risk analyses, usability reports, verification protocols, and traceability matrices. These elements support submissions to FDA, Health Canada, and EU MDR authorities.