A digital assessment platform designed to help medical device organizations identify compliance gaps, evaluate process maturity, and make informed decisions before they become audit findings or project delays.
Whether you're preparing for an audit, planning a new product, strengthening your quality system, or evaluating engineering capacity, TRACE provides structured assessments that transform complex challenges into actionable insights.
Medical device organizations generate large volumes of quality, engineering, regulatory, and product documentation throughout the product lifecycle. Understanding where gaps exist before they impact compliance, timelines, or business performance is often difficult.
TRACE brings together a suite of structured assessments designed to help organizations evaluate their current state across multiple business functions using a consistent, data-driven approach.
Rather than relying on assumptions, TRACE helps you understand where you stand and where improvements should be prioritized.
Data-Driven Insights
Structured assessments that go beyond gut feel.
Consistent Framework
Evaluate multiple functions using the same rigor.
Actionable Outputs
Clear recommendations and prioritized next steps.
Medical Device Focus
Built specifically for quality, regulatory, and engineering workflows.
Detect process and documentation gaps early.
Focus resources on the areas that matter most.
Receive structured insights based on your responses.
Use assessments to monitor progress over time.
Designed around quality, regulatory, engineering, and operational workflows.
TRACE covers four key areas of your medical device organization.
Evaluate quality management processes, documentation maturity, audit readiness, CAPA, change control, and inspection preparedness.
Assess development planning, design controls, design history files, traceability, verification, validation, and engineering documentation.
Review labeling, packaging, technical documentation, and regulatory readiness.
Understand engineering capacity, supplier quality, manufacturing readiness, localization opportunities, and cost optimization.
Four simple steps from assessment to action.
Select the assessment that best matches your current challenge.
Respond to structured questions based on your current processes.
Get a summary highlighting strengths, gaps, and opportunities.
Discuss findings and recommended next steps with our specialists.
Every TRACE assessment provides a comprehensive set of insights.
TRACE is designed for professionals involved in medical device development, quality, regulatory compliance, and manufacturing.
TRACE is developed by Helixa, SolidPro's Healthcare & Life Sciences division, combining engineering expertise with quality and regulatory knowledge to support medical device organizations throughout the product lifecycle.
Whether you're building a new product, preparing for an audit, optimizing engineering resources, or strengthening compliance, TRACE helps you begin with a clear understanding of your current state.
Choose from a range of structured assessments across four categories.
Every improvement starts with understanding your current state. Choose the assessment that matches your challenge and receive structured insights to help guide your next steps.