PSL and Fortive-Backed Certivo Secures Investment from PSV, Fortive, and AI Studio Fund

PSL and Fortive-Backed Certivo Secures Investment from PSV, Fortive, and AI Studio Fund

Simplify Compliance Without
Compromising on Safety or Speed

Simplify Compliance Without
Compromising on Safety or Speed

Simplify Compliance Without
Compromising on Safety or Speed

Medical device manufacturers face some of the world’s strictest regulatory requirements. Compliance is non-negotiable
— but it’s also a major bottleneck.

Medical device manufacturers face some of the world’s strictest regulatory requirements. Compliance is non-negotiable
— but it’s also a major bottleneck.

Medical device manufacturers face some of the world’s strictest regulatory requirements. Compliance is non-negotiable
— but it’s also a major bottleneck.

Manual document collection, changing global regulations, and demanding customers create constant delays and risk.

Manual document collection, changing global regulations, and demanding customers create constant delays and risk.

Manual document collection, changing global regulations, and demanding customers create constant delays and risk.

Certivo helps medical device teams streamline compliance, eliminate documentation gaps, and launch confidently — faster.
Certivo helps medical device teams streamline compliance, eliminate documentation gaps, and launch confidently — faster.
Certivo gives you the visibility, control, and automation you need to stay ahead of compliance risk
— without slowing down operations.

Try Certivo Free for 30 Days

Try Certivo Free for 30 Days

Try Certivo Free for 30 Days

Top Compliance Challenges in Medical Device Manufacturing

Top Compliance Challenges in Medical Device Manufacturing

Top Compliance Challenges in Medical Device Manufacturing

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Constantly Evolving Regulatory Requirements

Constantly Evolving Regulatory Requirements

You’re navigating multiple frameworks

You’re navigating multiple frameworks

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FDA 21 CFR (US)

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EU MDR

EU MDR

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ISO 13485

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RoHS, REACH, Prop 65

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Customer-specific declarations (e.g. from hospital systems or OEM partners)

Certivo keeps track of all of them — automatically monitoring changes, highlighting affected products, and alerting your team with clear next steps.

Certivo keeps track of all of them — automatically monitoring changes, highlighting affected products, and alerting your team with clear next steps.

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Burden of Documentation

From BOMs and SDSs to Declarations of Conformity and test reports — missing or incorrect documentation leads to failed audits, blocked shipments, or loss of trust.

From BOMs and SDSs to Declarations of Conformity and test reports — missing or incorrect documentation leads to failed audits, blocked shipments, or loss of trust.

Certivo automates the collection, validation, and organization of:

Certivo automates the collection, validation, and organization of:

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Supplier Certificates

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Full Material Declarations (FMDs)

Full Material Declarations (FMDs)

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Safety Data Sheets (SDSs)

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Country- or customer-specific compliance forms

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High Mix, Low Volume = Compliance Chaos

High Mix, Low Volume = Compliance Chaos

Many medical device companies deal with a wide variety of SKUs and a long tail of niche parts. Certivo scales with you — managing 500 or 50,000+ parts across different product families, regions, or risk profiles.

Many medical device companies deal with a wide variety of SKUs and a long tail of niche parts. Certivo scales with you — managing 500 or 50,000+ parts across different product families, regions, or risk profiles.

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Multi-Tier Supplier Complexity

Multi-Tier Supplier Complexity

Your compliance depends on documentation from hundreds of suppliers — often Tier 2 or Tier 3 — who aren’t always responsive.

Your compliance depends on documentation from hundreds of suppliers — often Tier 2 or Tier 3 — who aren’t always responsive.

Certivo drives

Certivo drives

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90% supplier response rates

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Automated outreach and follow-up

Automated outreach and follow-up

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Language translation and communication management

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Centralized dashboards to track responsiveness by supplier and product

What Certivo Unlocks for Medical Device Teams

What Certivo Unlocks for Medical Device Teams

What Certivo Unlocks for Medical Device Teams

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Faster product launches and market access

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Streamlined audits and inspections

Streamlined audits and inspections

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Full traceability from material to finished device

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Proactive regulatory alerts and updates

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Time savings for RA/QA teams by 80–90%

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Confidence in documentation during FDA, Notified Body, or internal reviews

"There’s no system today. It’s all manual. With 37,000 parts, that’s not sustainable."

— Compliance Manager, Becton Dickinson

— Compliance Manager,
Becton Dickinson

"This would have saved us months of effort — especially when preparing submissions for the EU MDR transition."

— Former RA Specialist, Medical Device OEM

— Former RA Specialist,
Medical Device OEM

How Certivo Works With You

How Certivo Works With You

How Certivo Works With You

CORA, our intelligent compliance agent, helps you

CORA, our intelligent compliance agent, helps you

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Monitor frameworks like EU MDR, ISO 13485, RoHS, REACH

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Collect supplier certifications with intelligent automation

Collect supplier certifications with intelligent automation

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Parse and organize documents into audit-ready formats

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Flag at-risk parts and expired certs in real time

And you’re supported by your dedicated Certivo Compliance Manager — no chatbots, no guessing.

And you’re supported by your dedicated Certivo Compliance Manager — no chatbots, no guessing.

Built for These Use Cases

Built for These Use Cases

Built for These Use Cases

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Implantables & disposables

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Diagnostic and laboratory equipment

Diagnostic and laboratory equipment

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Wearable health tech

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Imaging systems

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Hospital-grade electronics

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Devices integrating electronics, sensors, or software

Try Certivo — Free for 30 Days

Try Certivo — Free for 30 Days

Let us configure your environment, load your BOMs, and show you how Certivo can make compliance an asset — not a blocker.