Quality Assurance & Regulatory Compliance

We accelerate your product development and prepare it for certification

At CLEIO, our integrated design process follows the highest development standards. From concept to market, all our teams are involved and collaborate to make the product evolve according to the recommendations of our quality assurance experts.

What we do

Quality Management & Planning

Risk Management


Regulatory Compliance (US, CAN, EU)

Standards-based Analysis

Design History File (DHF)

Device Master Records (DMR)

Our quality management process follows the highest development standards

Our ISO-13485 certification means that our development activities are controlled and structured by audited and certified processes. These ensure our service quality and the satisfaction of our customers.

In addition, our teams develop your products according to applicable standards to meet the medical device’s regulatory requirements. Our process speeds up the time to market and facilitates product approval by the relevant authorities.

ISO 13485:2016

ISO 14971:2019

IEC 62304:2006/AMD1:2015

IEC 60601-1 Ed. 3.2

IEC 62366-1:2015/AMD1:2020

Our quality assurance team guides you through regulatory compliance activities

Working with CLEIO gets you high-level assistance in the planning of the following development activities required by medical standards:

Plan activities and quality controls related to the medical product development

Managing the product development and documentation

Leading the risk management process

Supporting the teams in normative analysis and regulatory strategies

Estimate efforts and time required to complete the activities

CLEIO helps your team navigate the regulatory environment

Every medical device has a class related to its risk. It helps define the constraints the product must meet to comply with regulatory requirements.

Our quality assurance team can support your team in becoming familiar with the medical standards and the regulatory process. Our role is to analyze the standards and regulations to establish the design requirements according to the identified specifications.

Design documentation

Our quality assurance team offers you a documentation framework to meet the medical product development process needs.

Identify documentary deliverables

Provide documentation templates

Redact the documentation (plans, reports, etc.)

Manage document reviews and approvals

Ensure documents traceability

Develop and maintain the technical product file, Design History File (DHF), and Device Master Records (DMR)

Risk management

Risk management is an essential factor in medical product development. Our quality assurance experts ensure that risk analysis and management activities are carried out throughout the development process.

Want your innovative ideas to create a positive impact?

Our experts got your back.