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.
Our process speeds up the time to market and facilitates medical device approval by the relevant authorities.
ISO 13485:2016
ISO 14971:2019
IEC 62304:2006/AMD1:2015
IEC 60601-1 Ed. 3.2
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.
Our quality assurance team offers you a documentation framework to meet the product development process needs.
Risk management is an essential factor in product development. Our quality assurance experts ensure that risk analysis and management activities are carried out throughout the development process.
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