Design and Development Services
Design controls are the backbone of a defensible product. When intended use, requirements, usability and risk are connected to verification, validation and labeling, you cut months of rework later. We build a traceable development flow for hardware, software as a medical device and diagnostics, and we fit it to your stage gate model or provide a lean program office that grows with you.
Regulatory Affairs Services
Choosing the right route shapes testing, clinical burden, timelines and labelling. Getting this right early prevents costly pivots. We map the optimal compliant path for MDR or IVDR and for FDA aligned with the business strategy, align the evidence plan, and build submissions that tell one coherent story across risk, usability, clinical and quality.
Quality Assurance
A usable quality system creates consistency, speeds decisions and keeps you inspection-ready. A bloated system stalls progress and a thin one breaks under scrutiny. We build ISO 9001 or ISO 13485 aligned systems that are right sized to your risk and scale and connect design controls, risk, clinical, production and post market activities to one traceable backbone.
Training Services
Capability is often the real bottleneck. When R&D, quality, regulatory, clinical, and operations share a common understanding, there is less rework and smoother reviews. We run practical courses that use your own artifacts and tools, so learning turns straight into better documents, tests, and submissions.
