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SDA has recently begun providing development and testing services to the medical industry. Services include; system design, software design, software development, and testing. Furthermore, we can help ensure that your product is compliant with the following industry standards:

  • General Principles of Software Validation; Final Guidance for Industry and FDA Staff
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
  • ISO 14971
  • IEC 62304
  • IEC 60601-1 3rd Edition

If you are in need of engineering services to bring your innovative ideas to life, please contact us. We can help you to accomplish this in a cost effective manner while ensuring compliance with regulatory guidelines.

Related Experience

In the past, SDA has assisted in tasks such as:

  1. Defining the testing and development process for medical devices.
  2. Creating automated test systems for medical devices.
  3. Developing the verification and validation tests (test protocols) for medical products. This includes testing using both manual methods and     automated scripts.
  4. Creating the software requirements for medical devices.
  5. Prototyping functionality in medical devices for customer evaluation.

"When performance is lacking, go with the alternative: Software Development Alternatives"
David W. Dodson, President and CEO, SDA Inc.