System Requirements & Specifications

Translating Ideas into Clear, Testable Product Blueprints

At PulseForward, we specialize in transforming clinical and business needs into structured, traceable, and verifiable system requirements. A well-written set of requirements and specifications is the foundation for compliant design, effective development, and successful regulatory submissions. We help your team define what the system must do, how it must perform, and under what constraints—ensuring alignment across engineering, quality, and regulatory.

Our Services Include:

• User & Stakeholder Needs Definition – Gathering and refining inputs from users, clinicians, regulatory bodies, and business units to shape system goals.

• System Architecture & Functional Decomposition – Breaking down high-level functions into clearly defined subsystems and components with defined interfaces.

• Requirements Authoring (URS, SRS, HRS) – Writing well-structured User Requirements (URS), System Requirements Specifications (SRS), and Hardware Requirements (HRS) documents.

• Traceability & Design Inputs Mapping – Creating full traceability from requirements to risk controls, design inputs, and verification protocols.

• Specifications for Embedded Systems & Software – Defining performance specs, software features, cybersecurity constraints, and integration requirements.

Why It Matters:

Ambiguity in system requirements leads to project delays, failed tests, and regulatory headaches. PulseForward brings engineering precision and regulatory awareness to your product definition process. Our documentation meets the expectations of standards like IEC 62304, ISO 13485, and FDA Design Control regulations—while giving your team a shared language to build the right product, the right way.