SechMed is a medical device design and development company supporting innovators from early concept through to regulatory clearance.

We provide hands-on execution across the critical, often under-resourced stages of medical device development. We do not operate as a purely advisory consultancy; we embed as execution partners and take ownership of defined activities.

Our focus is on bridging the gap between early innovation and compliant, manufacturable, regulatory-ready products. Alongside engineering and development execution, we establish foundational systems within client companies essential for long-term success, including quality management systems, design controls and risk management.

SechMed works with early-stage startups, university spin-outs, SMEs, and established companies requiring additional development bandwidth.
Our services include:

• Medical Device Design & Development – End-to-end development support from concept through to manufacturing.

• Quality Management Systems & Design Controls – Establishing and implementing fit-for-purpose QMS and design control aligned with ISO 13485.

• Risk Management & Usability Engineering – Early and ongoing risk analysis and usability activities aligned with IEC 62366-1 and ISO 14971.

• Verification, Validation & Testing Strategy – Planning and execution of V&V activities to support regulatory readiness.

• Regulatory Strategy & Submissions – Regulatory support including pathway definition, technical file development, and FDA and CE-mark applications.

• Project Planning & Delivery Management – Structuring development activities into clear, time-bound plans with defined responsibilities.

• Manufacturing Transfer & Supplier Support – Supplier qualification and design transfer.

At every stage, SechMed prioritises clarity, execution quality, and progression to market. Our approach reduces development risk, shortens timelines, and delivers devices that meet client and regulatory requirements.

SechMed Ltd

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