Regulatory Intelligence Platform

Regulatory Information Management System for medical devices.

Automate EU MDR, IVDR, FDA 510(k) and global submissions from a single European data model. Built for QM & RA teams to enable their innovation. Fully operational in just 8 weeks.

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CertHub RIMS dashboard, regulatory information management system for medical devices

70%

Less repetitive compliance work across QMS & TechDoc

2hvs 12h

Effort per regulatory change

8weeks

From kick-off to full operation

100%European

data centers located in Frankfurt

The challenge

Manual compliance is breaking
your RA team.

A single Class IIb medical device requires hundreds of interconnected documents across QMS, Technical Documentation, and labeling. As your portfolio grows, manual compliance doesn't scale.

Errors & Redundancies

Identical data duplicated across files with no system-level linkage or traceability,every copy is a future audit finding.

Lost in Traceability

MDR Annex II demands full traceability from intended purpose to clinical evidence. Manual handling, impossible at scale.

Portfolio Explosion

Each new product or market multiplies compliance risk exponentially. Linear teams cannot manage exponential complexity.

The CertHub approach

Your regulatory operating system.

CertHub RIMS connects product data, technical documentation, QMS, and global submissions into a single coherent workflow.

Single Source of Truth

Data is defined once and referenced everywhere,eliminating duplication, version drift, and audit surprises across your entire portfolio.

AI Impact Analysis

When a product or regulation changes, CertHub runs an AI impact analysis and updates all affected documents automatically,12 hours becomes under 2.

Worldwide from One Model

EU MDR, IVDR, AI Act, FDA 510(k), UK MDR, Swissmedic, ANVISA, TGA,all generated from the same regulatory data model.

Platform

Everything your RA team needs.

Six essential capabilities to get all the job done all in one place.

Fast Track to Certification

Guided, automated setup of tailored certification content for MDs, IVDs, and SaMDs. Pre-certification workflow that cuts time-to-submission by 60%.

60% faster submissions

1-Click Technical Documentation

Generating and maintaining medical device data, QMS, TechDoc and version management automatically.

70% fewer repetitive tasks

Bidirectional Change Management

Product change or regulatory update? CertHub's AI propagates the impact across your entire portfolio in real time,flagging affected products, refreshing Annex II/III documents, and preparing submission packages before the Notified Body asks.

83% time saved per change

TechDoc Compliance Checker

Simulate a TechDoc review by a Notified Body before submission. Receive a compliance score, prioritized gap report, and expert debrief.

QMS Audit Checker

Simulate a QMS review before audit. Receive a prioritized gap report and remediation plan,so findings come from you, not the Notified Body.

Any Data Source. Any Format.

Jira, Polarion, DOORS, Dassault, Word, Excel, legacy eQMS, PDFs, scans,CertHub ingests any format and structures it into the regulatory data model automatically via AI. No manual re-entry required.

Global reach

Submit worldwide from one European platform.

Eight jurisdictions. Three databases. One regulatory data model. Your evidence stays in Europe,your products reach every market.

MDR 2017/745 · IVDR · AI Act

EUDAMED · GSPR traceability · MDCG-aligned

FDA 510(k) · QMSR

21 CFR Part 820 · Predicate mapping

MHRA / UK MDR

Post-Brexit UKCA conformity

Swissmedic / MedDev Ordinance

Swissdamed registration

ANVISA

INMETRO certification

Health Canada · CMDR

MDSAP-compatible

TGA

ARTG inclusion

IMDRF · MDSAP

International harmonization

Connected databases EUDAMED Swissdamed GUDID

Security & data protection

100% European servers.

CertHub is developed and hosted in Germany. Your data never leaves Europe,no US partners, no third-country transfers, no vendor lock-in.

Encrypted communication

HTTPS, TLS 1.2+ end-to-end throughout

Isolated VPC

No direct internet access to sensitive systems

Open Policy Agent (OPA)

Role-based access,same standard as BMW and Atlassian

Identity-aware access

Authenticated, traceable, revocable,by role and context

Certifications

GDPR / DSGVO

Fully compliant · German jurisdiction

ISO 27001

Information Security Management

ISO 80002-2

Validation of process software

100% EU Hosting

AWS Frankfurt · No third-country transfers

Business case

The ROI of RIMS,calculated.

One Intended Use Statement update. Manual: 12 hours. With CertHub: 2 hours. Across 6 regulatory changes per year, 300 hours saved, per jurisdiction.

30k€

Saved per year per jurisdiction
(at 100 €/h · 300 hours)

−83%

Time per regulatory change

300h

Hours saved per year
per jurisdiction

	Manual	CertHub RIMS
Per regulatory change	60h	10h
Per year (6 changes)	360h	60h
Time reduction	—	−83%
Hours saved per year	—	300h
Cost saved per year	—	30,000 €

Onboarding

Operational in 8 weeks. No IT projects.

No 18-month digital transformation. No manual data re-entry. No disruption. CertHub's pragmatic onboarding delivers measurable productivity within weeks.

Phase 1

Week 1

Kick-Off & Status Quo

Requirements identified, system access granted, existing documentation assessed.

Phase 2

1 day + 1 week

Setup & Configuration

Templates, forms, and SOPs created. Platform configured to your regulatory scope.

Phase 3

2 weeks

Training

Users onboarded via tutorials and guided sessions. Team ready to operate independently.

Phase 4

2 weeks

Integration & Go-Live

Data transferred from existing systems, feedback loops activated, first submissions prepared.

Phase 5

Ongoing

Continuous Operation

AI structures incoming data, regulatory changes monitored, submissions automated across all jurisdictions.

Trust & expertise

Built by regulatory experts.
Trusted by the industry.

20+

Recognized regulatory and industry experts on the team

50+

Years of combined domain experience in MedTech compliance

Best Startup in Healthcare · Robert Habeck Award recipient

Ready to transform regulatory affairs from cost center to growth enabler?

Open new global markets faster, without proportional cost increase. Let CertHub RIMS handle the complexity,while your team focuses on strategy.

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Frequently Asked Questions About RIMS for Medical Devices

What is a Regulatory Information Management System (RIMS) for medical devices?

How does CertHub RIMS differ from traditional compliance software?

Is CertHub RIMS compliant with EU MDR 2017/745 and EU IVDR 2017/746?

How long does it take to implement a RIMS for a MedTech company?

Can RIMS handle multiple medical device products across different markets simultaneously?

What happens when regulations change, like a new MDCG guidance or ISO standard revision?

Is CertHub RIMS GDPR compliant and where is data stored?

Does CertHub RIMS support FDA 510(k) submissions as well as EU MDR?

What is the ROI of implementing a Regulatory Information Management System?

Can CertHub RIMS import data from our existing eQMS, Word, or Excel documents?