Hyfe’s approach to product validation and quality management is grounded in a comprehensive Quality Management System (QMS) that integrates industry standards, regulatory expectations, and internal governance structures. Hyfe’s processes for validating its medical technologies are rigorous, repeatable, and tightly aligned with internationally recognized frameworks.
The Design Validation procedure outlines a formal, controlled process for demonstrating that Hyfe’s hardware and software products meet user needs and intended uses through objective evidence. It explicitly references external regulatory standards—including ISO 13485, IEC 62304, 21 CFR 820, and FDA validation guidance—signaling that validation activities are embedded within a broader QMS consistent with global medical device expectations. The document establishes defined roles, responsibilities, and independence requirements, ensuring that validation is led by qualified personnel, reviewed by QARA, and independently assessed by knowledgeable reviewers. This structure fulfills the V3+ principle of demonstrating that validation is systematic, unbiased, and traceable.
The process descriptions reinforce the V3+ emphasis on lifecycle-appropriate validation. Validation activities are tailored to product risk, complexity, and intended use, ensuring that devices with higher safety impact receive more extensive evaluation. The procedure mandates that validation be grounded in documented user and product requirements, not engineering assumptions, and that results be connected back to those requirements through formal traceability. Formative and summative elements appear in the planning, execution, deviation handling, and reporting phases, providing clear checkpoints for confirming that a product continues to meet expectations from early development through formal release. This alignment with structured evidence generation is foundational to V3+ verification.
The Hyfe Quality Policy demonstrates organizational alignment behind the QMS and the processes outlined in the Design Validation procedure. The policy commits Hyfe to maintaining the highest standards of quality across operations, emphasizing patient-centric innovation, regulatory compliance, and continual system improvement. The extensive signatory table—including executives from product, data science, medicine, operations, and experience design—indicates that quality is not siloed within QARA but is embraced company-wide. This broad accountability structure is consistent with a mature QMS in which validation activities are not administrative exercises but are central to product development and risk management.
The Design Validation procedure further embeds QMS integration through explicit references to related controlled documents, including Design Reviews, Problem Resolution processes, Clinical Evaluation procedures, Process Validation, and Change Control. This interconnectedness shows that validation is not an isolated activity but part of a cohesive system linking requirements, risk management, design controls, and post-market updates. The requirement that all validation plans, reports, and summary reports be stored in controlled QMS repositories ensures traceability and audit readiness.
The structured planning and documentation requirements—such as defining validation scope, acceptance criteria, personnel qualifications, enabling systems, and statistical techniques—demonstrate that Hyfe’s validation activities follow a disciplined, reproducible methodology. The expectation that all deviations be documented and that all validation activities be captured within Design Review meeting minutes ensures transparency and control. The requirement for independent review safeguards objectivity, while the use of controlled templates (e.g., validation plans, validation reports, and summary validation reports) promotes consistency across teams and product lines.
The Quality Policy complements these operational controls by articulating a shared commitment to excellence and patient impact. The policy reinforces that quality is integral to Hyfe’s mission and not merely a compliance obligation. The broad executive endorsement of the policy illustrates top-level ownership of the QMS and confirms that validation processes are supported by leadership across the organization.
Hyfe’s products undergo structured, risk-appropriate validation. This ensures that user needs and intended uses form the foundation for all verification activities; that documentation, independence, and traceability are consistently maintained; and that quality is embedded into the organization at every level. Hyfe has a comprehensive Quality Management System including an explicit quality policy and design validation protocol. These two documents are available below. Further QMS documents are available upon request.