Software Essentials develops embedded firmware and software and produces regulatory documents for medical devices under both FDA guidance documents and IEC 62304 classes A, B, and C.

We understand the necessary design controls, usability, and quality and regulatory standards for medical device software. We have designed and shipped several successful products for US, EU, Canada, and Japan. We have participated in several FDA and EU Notified Body software inspections, and we take pride in our design history documents.

We are very passionate and accountable for delivering high-quality products on time and on budget.

Software Essentials

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