How We Work

SechMed’s process is built to take devices through the entire development journey, from first ideas to regulatory approval and market release. Our structured approach keeps projects moving forward with clarity, embedding compliance at every stage and ensuring that outcomes are safe, effective, and approval-ready.

SechMed can deliver the full development lifecycle, where our approach adds the most value, but our framework is also flexible enough to provide targeted support at critical stages, applying the same structured oversight and compliance focus to specific objectives within a broader programme.

The result is a development pathway that is clear, efficient, and regulator-ready, whether managed end-to-end or strengthened at a key stage.

Flowchart illustrating stages of project development: concept and design, development and engineering, market clearance, with overarching project management and regulatory strategy at the top and bottom.

Project Management & Oversight

At the top level, we apply disciplined project management to align milestones, budgets, and risks. This creates clear decision points and full visibility, so that technical progress, regulatory needs, and commercial objectives stay tightly connected.

Concept & Design → Development & Engineering → Market Clearance

At the core of our process is the progression of your device itself. Early concepts are translated into structured designs, developed through prototyping and engineering, and refined into manufacturable products. From there, we prepare devices for production, validate processes, and manage the transition into manufacturing and market clearance.

Regulatory & Compliance in Parallel

Running alongside every stage, our regulatory expertise ensures that design history files, technical documentation, and risk management evolve in step with the device. By integrating regulatory strategy throughout, we remove bottlenecks and avoid the late-stage delays that can stall otherwise strong programmes.

Services We Offer

  • Technology Assessment

  • Device Design

  • Contract Manufacturer selection

  • Project Planning and Budgeting

  • Usability/Human Factors Testing (IEC 62366)

  • Risk Management (ISO 14971)

  • Develop device specifications and Drawings

  • Process development

  • Packaging Development and Testing

  • Tooling and Fixture Design

  • IFU development and translation

  • IFU development and translation

  • Process Validation

  • Sterilisation Validation

  • Design Verification

  • Design  Validation: In Vivo or In Vitro testing

  • Biocompatability testing

  • Biocompatability Report

  • Design Transfer

  • Regulatory support; Pre-Submission meetings and Submission Documentation

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