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.
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.
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.
Select the assessment that best matches your current challenge.
Answer a series of structured questions based on your organization's current processes.
Receive an assessment summary highlighting strengths, potential gaps, and improvement opportunities.
Review recommended next steps and discuss the findings with our specialists if additional support is required.
Every TRACE assessment provides:
TRACE is designed for professionals involved in medical device development, quality, regulatory compliance, and manufacturing.
Quality Managers
Regulatory Affairs Professionals
Engineering Managers
Product Development Teams
Manufacturing Leaders
Operations Managers
Medical Device Startups
OEMs
Contract Manufacturers
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.
Start with a clear understanding of your current state—before you decide what's next.
"Every improvement starts with understanding where you stand."
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.