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.
| Website | http://www.softessn.com |
| Employees | 5 (2 on RocketReach) |
| Founded | 1995 |
| Technologies |
Apache
,
Apache HTTP Server
,
Linux
+2 more
(view full list)
|
| Industry | Software Development |
| Keywords | Medical Device Software, Embedded Firmware, Software Development, Embedded Systems, Firmware Engineering, Regulatory Documents, Software Engineering, Regulatory Compliance, Fda Regulations, Software Quality, Iec Standards, Quality Assurance, Software Validation, Usability Testing, Risk Management |
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Sandra Vines is the Owner of Software Essentials.
2 people are employed at Software Essentials.
Software Essentials is based in Belmont, Massachusetts.
Top Software Essentials Employees
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Sandra Vines
Owner at Software Essentials
Newark, NJ, US25 -
12
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