Open Regulatory (MDR Templates Library)
OpenRegulatory
OpenRegulatory offers AI-powered eQMS software and consulting for medical device compliance, simplifying EU MDR, FDA, and Health Canada audits for lean teams.
OpenRegulatory provides an AI-powered eQMS called Formwork, designed for lean teams to streamline medical device compliance for EU MDR, FDA, and Health Canada. Their mission is to make regulatory compliance transparent, accessible, and free, offering open templates, pricing, and a playbook. Formwork replaces traditional tools like Google Drive and Jira with a purpose-built system that passed EU MDR and FDA audits. They also offer consulting services, including workshops and pay-as-you-go support, to help companies navigate classification, certification roadmaps, and documentation. Their Formwork eQMS comes in various editions, including a free Community Edition, a Starter package, and a comprehensive QMS + Techdoc tier. These solutions are built to be ISO 13485 and EU MDR ready, featuring real-time completeness checks, audit-proof e-signatures (FDA 21 CFR Part 11), and advanced AI features for document generation. OpenRegulatory emphasizes transparency and accessibility, providing free learning resources and a community forum alongside their paid offerings.
About
**Who they are**
Open Regulatory (MDR Templates Library) provides AI-powered eQMS software and consulting services focused on medical device compliance. They aim to simplify complex regulatory processes for lean teams.
**Expertise & scope**
* Specializes in EU MDR, FDA, and Health Canada compliance.
* Offers AI-powered eQMS software solutions.
* Provides consulting services for medical device compliance.
* Focuses on simplifying audits for smaller teams.
**Reputation / proof points**
* Coverage includes the EU market.
Open Regulatory (MDR Templates Library) provides AI-powered eQMS software and consulting services focused on medical device compliance. They aim to simplify complex regulatory processes for lean teams.
**Expertise & scope**
* Specializes in EU MDR, FDA, and Health Canada compliance.
* Offers AI-powered eQMS software solutions.
* Provides consulting services for medical device compliance.
* Focuses on simplifying audits for smaller teams.
**Reputation / proof points**
* Coverage includes the EU market.
Additional information
OpenRegulatory's solutions are designed to streamline the often-complex landscape of medical device regulations, including EU MDR, FDA, and Health Canada requirements. Their AI-powered eQMS software and consulting are particularly beneficial for lean teams needing to navigate audits efficiently. Buyers should consider how their specific device classification and target markets align with OpenRegulatory's stated coverage areas. Engagement typically involves leveraging their software for documentation management and potentially consulting support for strategic compliance planning.
Key Highlights
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AI-powered eQMS software and consulting for medical device compliance.
Source
“OpenRegulatory offers AI-powered eQMS software and consulting for medical device compliance”
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Simplifies EU MDR, FDA, and Health Canada audits.
Source
“simplifying EU MDR, FDA, and Health Canada audits for lean teams.”
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Coverage includes the European Union.
Source
“Coverage: EU”
Certifications & Trust Signals
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Provider focuses on simplifying complex regulatory landscapes.
Source
“simplifying EU MDR, FDA, and Health Canada audits for lean teams.”
Buyer Snapshot
Best for
- Lean teams managing medical device compliance
- Companies seeking AI-powered eQMS solutions
- Organizations navigating EU MDR, FDA, or Health Canada regulations
How engagement typically works
- Software subscription for eQMS
- Consulting support for compliance strategy
Typical deliverables
- AI-powered eQMS software
- Compliance documentation templates
- Audit simplification support
Good to know
- Best when focused on EU, US, or Canadian markets
- Most effective for teams prioritizing efficiency in compliance processes
HQ:
Stockholm, DE
Languages:
English
Timezones:
Europe/Stockholm
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU
Countries:
SE, DE, FR, NL, BE
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
1-5
Onboarding time:
4–12 days
Pricing model:
Per project
Starting from:
EUR 500
Included services:
Importer/Distributor SOP & template pack, Compliance gap scan, Audit readiness support
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
Templates pack, Training, Audit support
Training Format:
Recorded
Role Coverage:
Both
Additional importer_distributor_compliance Details
Role Coverage
Importer, Distributor, importer, distributor
Supports MDR
Yes
Supports IVDR
No
Verification Support
Yes
Onboarding Steps
Offers workshops for initial analysis and provides step-by-step to-do lists for certification.
