IEC 62304 – Regulatory Consulting for Medical Device Software (SaMD)
What we offer
Implementation of IEC 62304 into your complete product life cycle
Design of software development processes that will not slow down your development team
Practical guidance on the implementation of regulatory requirements
Alignment with Agile development, cloud solution and automated CI/CD pipelines
Internal audits of your Technical File
Improvements in technical documentation, including software architecture
Preparation for external audits, CE certification and FDA submission
Why Work With Us
We develop software on our own, and therefore, our knowledge is based on practical experience.
We participated in the software development of many medical devices.
We passed multiple medical device software CE certification audits.
We use CI/CD, automated tests, and cloud solutions in our daily work, and we know how to practically align them with regulatory requirements.
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