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This document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations to ensure compliance to ISO 10993-1.
The Quality Assurance plan includes the documentation of the project quality, the responsibilities of the quality activities, regulatory approvals, inspections and test activities and ensuring whether the acceptance criteria have been met.
A recommended template which will guide you through the regulatory requirements to fulfil your claims.
The usability checklist is intended to obtain suitable usability of the medical device, by minimising the error and the risk related to the use of the device that are able to be amendable by the manufacturer.