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Voler Whitepaper: Developing Product Requirements for Medical Devices

Learn how to write product requirements for medical devices that aid in a more rapid approval process.

Our samples will show how to clearly and unambiguously articulate the product’s functionality and behavior while providing solid V&V evidences for FDA approval. Download the product requirements for medical devices whitepaper

product requirements medical devices Requirements Medical Devices2

Best Practices for Developing and Writing Requirements

  • All requirements must be testable and can fail when testing in a predictable way to prove implementation is correct. o Make sure each requirement is complete. A requirement can reference other requirements if there are dependencies.
    • Avoid duplicate requirements
    • Avoid contradictory requirements
    • It is preferred to write the requirement statement in positive terms. It is easier to prove a system can do something or has a characteristic than to prove it can’t or doesn’t.
    • Use your cross-functional team to review requirements for testability. They will help you identify conflicting requirements within your documentation.
  • Requirements should be quantifiable and repeatable. Try to avoid qualitative requirements that add subjective decision making during implementation and verification.


The PRD serves as a contract between the Marketing and Engineering groups to ensure the company is creating and delivering the right product to their customers. Ensuring that all the requirements are identified can take time to analyze and develop; however, this effort is well spent providing clear design specifications to the engineers on what to develop and to the V&V engineers on what to test.

Summary of resources

MRD Template

PRD Template

SRS Template

About Voler System

Voler Systems provides R&D consulting from concept through smoothly moving new products into production. Since 1979, clients have turned to us for reliable new products involving sensors and measurement electronics. Our highly experienced team delivers high quality products on time and on budget. We have developed wearable devices, IoT devices, medical devices, consumer products, and other specialized sensor-based electronics and prototype circuits.

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