Now accepting early access partners

Validation that moves
at the speed of science.

EVOLV | The Validation Factory

The first AI-native Computer System Validation platform built for GAMP 5, 21 CFR Part 11, and FDA QMSR. Generate compliant URS, automate risk assessment, and govern AI model changes — in minutes, not months.

Request Early Access ▶ Try Live Demo
GAMP 5 21 CFR Part 11 21 CFR Part 820 QMSR ISO 13485:2016 FDA PCCP Guidance Aug 2025 GMP Annex 11 EU GMP

The Problem

CSV validation still runs on
spreadsheets and email chains.

Life sciences teams spend months on documentation that should take days. Regulatory guidance has changed. Most platforms haven't.

📋

Weeks to generate a URS

Requirements written manually in Word, reviewed in meetings, rewritten after audit findings. No regulatory traceability. No version control. Just documents.

⚠️

Regulations change. VMPs don't.

FDA's QMSR replaced the QSR on February 2, 2026. The PCCP final guidance landed August 2025. Most validation plans still cite rules that no longer exist.

🤖

AI in GxP with no governance

Drug interaction predictors and defect classifiers are being deployed with no PCCP, no change control, no audit trail. FDA inspectors are starting to notice.

The Platform

One platform.
The entire validation lifecycle.

From first requirement to post-market governance — every step compliant, auditable, and powered by AI that knows GAMP 5.

📄

Validation Factory

Generate GAMP 5-compliant URS from plain English. SMART refinement, PCCP verification, UR/FR decomposition, CSA test scripts, and PDF export with e-signature — in one guided workflow. What took days takes minutes.

URS Generation SMART Refinement UR/FR Decomposition CSA Test Scripts PDF + E-Signature
🔄

Change Control

ServiceNow change requests cross-referenced against your system portfolio in real time. GxP classification, GAMP-aware risk calculation using Severity × Occurrence × Detectability, and automatic revalidation flags. No spreadsheet required.

ServiceNow Integration GxP Classification GAMP Risk Matrix Revalidation Flags
🤖

AI Model Governance

Validated AI models treated as GAMP Category 5 assets. PCCP-aware change assessment aligned to FDA final guidance August 2025. Human-in-the-loop approval queue with 21 CFR Part 11 compliant audit trail.

PCCP Assessment HITL Governance FDA Aug 2025 21 CFR Part 11
📊

Portfolio Dashboard

Every system, every site, every phase — one view. RAG status, action items, regulatory due dates. Register new systems with GxP classification and track their full validation journey from plan to monitor. Built for QA Heads and CTOs.

RAG Status System Registry Lifecycle Tracking Multi-Site

See It In Action

Watch EVOLV handle in 4 minutes
what takes your team weeks.

Three real workflows. No voiceover scripts. No slides. Just the platform doing what it's built to do.

Demo 01

Portfolio Dashboard

Your entire validated system landscape — GAMP category, GxP status, risk level, revalidation due dates — in one view. Built for QA Heads and CTOs who need portfolio-wide compliance visibility instantly..

Demo 02

Change Control & GxP Classification

ServiceNow CR received → portfolio cross-reference → GAMP risk calculation → revalidation decision. Automatic.

Demo 03

AI Model Governance

AI model change in a validated system → PCCP assessment → Governance Hub → human-in-the-loop approval → 21 CFR Part 11 audit trail. Built for FDA's final guidance (Aug 2025).

Try the Validation Factory — live, right now.

Generate a real GAMP 5-compliant URS from your own requirement. No login required.

▶ Open Live Demo

Built For

EVOLV speaks the language
of regulated industries.

Whether you're defending a validation package in an inspection or governing 150 systems across 25 sites — EVOLV gives you the records to back it up.

🧪 QA Head · CSV Manager

Stop writing in Word. Start validating.

EVOLV generates, verifies, and manages your entire validation portfolio with a complete audit trail FDA inspectors can review on the spot.

  • URS from plain English in minutes
  • SMART requirements, auto-verified against GAMP 5
  • Full lifecycle tracking — Plan to Monitor
  • Audit-ready PDFs with e-signature

📋 VP Regulatory Affairs

FDA updated the rules. EVOLV already knows.

QMSR is mandatory. PCCP guidance is final. EVOLV cites the right regulations, routes the right changes, and produces the records you need when an inspector walks in.

  • Aligned to FDA PCCP Guidance Aug 18, 2025
  • 21 CFR Part 820 QMSR / ISO 13485:2016
  • SHA-256 tamper-evident audit trail
  • 21 CFR Part 11 electronic records

💻 CTO · CDO

Your AI models are GAMP Cat 5 assets.

EVOLV gives you the governance infrastructure to deploy AI in GxP contexts without regulatory exposure — with a full HITL approval layer and immutable decision records.

  • AI model registry with version history
  • PCCP-aware change assessment
  • Human-in-the-loop governance hub
  • Portfolio-wide RAG visibility

Regulatory Coverage

GAMP 5 (2nd Edition) 21 CFR Part 11 21 CFR Part 820 QMSR ISO 13485:2016 FDA PCCP Guidance Aug 18, 2025 GMP Annex 11 EU GMP GLP ISO 17025 GDPR 21 CFR Part 820.35 QMSR FDA CSA Guidance 2022

Early Access

Join our first cohort of life sciences partners.

We're working with a small group of pharma and biotech companies before general availability. Early access partners get priority onboarding, direct access to the founding team, and founding-tier pricing locked in permanently.

🔒  We'll respond within 1 business day. Your information is never shared.

Choosing a Medical Device Consultant: Key Factors for Success

Sep 10, 2025

Understanding the Role of a Medical Device Consultant

When navigating the complex landscape of medical device development, a consultant can be an invaluable asset. They provide expertise in regulatory compliance, market strategy, and product development. By guiding you through each phase of bringing a device to market, they help ensure that your project is both successful and compliant with industry standards.

medical device consultant

Consultants are particularly crucial for startups and smaller companies that may lack the in-house resources to tackle these challenges alone. Their experience can significantly accelerate the development process, avoiding common pitfalls and ensuring that your device meets all regulatory requirements.

Identifying Your Needs

The first step in choosing the right consultant is to clearly identify your company's specific needs. Are you looking for help with regulatory submissions, or do you need strategic advice on market entry? Understanding these requirements will guide your selection process and ensure that you find a consultant whose skills align with your objectives.

Consider the scope of your project and the expertise required at different stages. Some consultants specialize in niche areas, such as clinical trials or quality assurance, while others offer more comprehensive services. It's essential to match their skills with your needs for an effective partnership.

Evaluating Experience and Expertise

When vetting potential consultants, their experience and expertise should be at the forefront of your decision-making process. Look for professionals who have a proven track record in the medical device industry, particularly in areas relevant to your project. Their past successes can be indicative of their ability to navigate future challenges effectively.

medical device expertise

Additionally, consider their familiarity with the latest technological advancements and regulatory changes. The medical device industry is rapidly evolving, and a consultant’s ability to stay updated is crucial to ensuring compliance and innovation.

Assessing Compatibility and Communication

Beyond technical expertise, a consultant's compatibility with your team is vital. Effective communication and collaboration are key components of a successful partnership. During initial meetings, pay attention to their communication style and how well they understand your company's culture and goals.

Establishing clear communication channels from the outset can prevent misunderstandings and foster a productive working relationship. Regular updates and feedback loops will keep your project on track and ensure that everyone is aligned on objectives and expectations.

Considering Cost and Value

While cost is an important factor when selecting a consultant, it should not be the sole determinant. Consider the value they bring to your project in terms of expertise, time saved, and potential revenue generation. A more expensive consultant with a higher success rate may ultimately offer better value than a cheaper alternative.

business consultation

It's also worth discussing any additional costs that may arise during the project to avoid surprises. Transparency in pricing will help you budget effectively and choose a consultant whose fees align with your financial resources.

Making the Final Decision

After evaluating potential consultants based on these factors, it's time to make your decision. Trust your instincts, but also rely on concrete data such as references and past client feedback. A well-chosen consultant will not only support your current project but can also become a long-term partner for future endeavors.

In conclusion, selecting the right medical device consultant involves careful consideration of your needs, their expertise, communication skills, and overall value. By taking the time to thoroughly evaluate potential candidates, you set the foundation for a successful partnership that can significantly impact your project's success.