Helixa — powered by SolidPro
TRACE™ v1.0Traceability & Regulatory Assessment · Compliance Engineering

Know where you stand before it becomes an audit finding.

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.

Free · About 3 minutes · Instant insights
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Start Your Assessment

Six fields. No sales call required.

Free · Instant results · No sales call required

The TRACE difference
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Data-Driven Insights

Structured assessments that go beyond gut feel.

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Consistent Framework

Evaluate multiple functions using the same rigor.

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Actionable Outputs

Clear recommendations and prioritized next steps.

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Medical Device Focus

Built specifically for quality, regulatory, and engineering workflows.

01 · Overview

What is TRACE?

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.

★ Why it works

One framework, every function

  • check_circleDetect process and documentation gaps early, before they surface in an audit.
  • check_circleCompare quality, product, regulatory and engineering functions on the same scale.
  • check_circleFinish with prioritized recommendations, not a list of observations.
  • check_circleRe-run it later to show progress over time.
02 · Benefits

Why TRACE?

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Identify Risks Before They Become Findings

Detect process and documentation gaps early.

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Prioritize Improvement Efforts

Focus resources on the areas that matter most.

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Make Better Decisions

Receive structured insights based on your responses.

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Support Continuous Improvement

Use assessments to monitor progress over time.

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Built for Medical Device Organizations

Designed around quality, regulatory, engineering, and operational workflows.

03 · Categories

Assessment Categories

TRACE covers four key areas of your medical device organization.

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Quality & Compliance

Evaluate quality management processes, documentation maturity, audit readiness, CAPA, change control, and inspection preparedness.

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Product Development

Assess development planning, design controls, design history files, traceability, verification, validation, and engineering documentation.

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Regulatory

Review labeling, packaging, technical documentation, and regulatory readiness.

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Engineering & Operations

Understand engineering capacity, supplier quality, manufacturing readiness, localization opportunities, and cost optimization.

04 · Process

How TRACE Works

Four simple steps from assessment to action.

1Choose

Select the assessment that best matches your current challenge.

2Answer

Respond to structured questions based on your current processes.

3Receive

Get a summary highlighting strengths, gaps, and opportunities.

4Review

Discuss findings and recommended next steps with our specialists.

Deliverables

What You'll Receive

Every TRACE assessment provides a comprehensive set of insights.

scoreOverall Assessment Score
analyticsMaturity Summary
checklistCompliance or Readiness Insights
warningIdentified Risk Areas
lightbulbImprovement Recommendations
flagSuggested Next Steps
Audience

Who Should Use TRACE?

TRACE is designed for professionals involved in medical device development, quality, regulatory compliance, and manufacturing.

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Why Helixa

Why Helixa?

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.

⚑ Built by Engineers, for Engineers
  • checkDeep medical device engineering expertise
  • checkQuality and regulatory domain knowledge
  • checkProven track record with medical device organizations
  • checkEnd-to-end product lifecycle support
Assessments

Explore Available Assessments

Choose from a range of structured assessments across four categories.

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Quality & Compliance

  • QMSR Readiness
  • Inspection Readiness
  • CAPA Assessment
  • Change Control Assessment
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Product Development

  • Product Development Readiness
  • Design Controls Assessment
  • DHF Assessment
  • Traceability Assessment
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Engineering & Operations

  • Engineering Capacity
  • Cost Opportunity Assessment
  • Localization Feasibility
  • Supplier Quality
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Regulatory

  • Labeling Compliance
  • Packaging Validation
Get started

Know Where You Stand Before
You Decide What's Next.

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.

Free · Instant results · No sales call required

Start Your TRACE Assessment

Free 3-minute assessment. Instant insights.

Free · Instant results · No sales call required