Quality Management & Planning
Risk Management
Regulatory Compliance (US, CAN, EU)
Standards-based Analysis
Design History File (DHF)
Device Master Records (DMR)
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
Working with CLEIO gets you high-level assistance in the planning of the following development activities required by medical standards:
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.
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.
