We have well-established processes for complex development projects in healthcare, diagnostics, life sciences, cell therapy and contract manufacturing.
Our quality systems are:
Certified to ISO 9001:2015 and ISO 13485:2016
In alignment with 21 CFR 820.30 and EU medical device regulations
Based on the IEC 62304 standard for software development processes
Designed to support our clients’ GMP compliance
Our quality systems are flexible, allowing client specific development plans to be created. This flexibility also provides our clients with the option to make adjustments such as transitioning from a non-regulated environment early in the development project to a regulated environment later on.
In addition to our focus on compliance and governance, continuous improvement activities are core to our quality systems. We utilize the Fortive Business System toolset, feedback from clients and production activities, as well as audits by clients and certification bodies to drive improvement.
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