Design controls are the backbone of a defensible product in MedTech, BioTech and Pharma. When intended use, requirements, usability and risk are connected to verification, validation and labeling, you avoid late surprises and months of rework.

 We build a traceable development flow for medical devices, software as a medical device, IVDs and diagnostics, and development programs where quality and evidence must be built in from the start. We fit the approach to your stage gate model or step in with a lean program office that grows with you. We also work closely with your internal teams and with trusted partners such as test laboratories, clinical collaborators and suppliers so plans, protocols and deliverables stay aligned. The outcome is a clean design history, clear decisions, and evidence that stands up in review and audit.

→ Project Management

Medical device projects involve research, clinical, manufacturing, supplier, and notified body aspects. Without organization, scope and documentation drift. We run integrated plans and design reviews, keep decisions logged, coordinate with test laboratories and suppliers, and maintain a clean design history file. You get transparent status and timely decisions, with documentation that is clean, compliant, and minimal.

→ Risk Assessment

Medical device projects involve research, clinical, manufacturing, supplier, and notified body aspects. Without organization, scope and documentation drift. We run integrated plans and design reviews, keep decisions logged, coordinate with test laboratories and suppliers, and maintain a clean design history file. You get transparent status and timely decisions, with documentation that is clean, compliant, and minimal.

→ Design Verification and Validation

Verification proves the product meets its requirements. Validation proves it works for users and its intended use. Weak planning here leads to retests and extended review cycles. We create traceable plans and lean protocols, coordinate accredited testing with our partners, handle deviations and nonconformities and deliver submission ready reports that match expectations in Europe and the United States.

→ Clinical Evaluation

Verification proves the product meets its requirements. Validation proves it works for users and its intended use. Weak planning here leads to retests and extended review cycles. We create traceable plans and lean protocols, coordinate accredited testing with our partners, handle deviations and nonconformities and deliver submission-ready reports that match expectations in Europe and the United States.

→ Usability Engineering

Use-related risks are a leading cause of delays, field issues, and regulatory questions. If usability is treated as a late test instead of a design driver, teams often face redesigns, relabeling, and extended review cycles. We integrate usability engineering from early design through validation, defining user profiles, environments and critical tasks, running formative evaluations, and leading summative usability validation aligned with IEC 62366 and FDA expectations. Findings are directly connected to risk controls, labeling, and training, so usability evidence strengthens both safety and market acceptance.

→ Design Transfer

Moving from development to manufacturing is where quality issues and delays often appear. If design outputs, acceptance criteria and production controls are not aligned, teams face deviations, rework and inspection risk as volumes grow.. We plan and execute controlled design transfer by defining transfer readiness criteria, aligning design outputs with manufacturing and GMP expectations, and ensuring traceability to verification, risk controls and labeling. We support device/batch records, process controls and change management, and coordinate suppliers or CMOs so the handover is clear, compliant and scalable.

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