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
Open Regulatory (MDR Templates Library) provides AI-powered eQMS software and consulting services focused on medical device compliance. They aim to simplify regulatory processes for EU MDR, FDA, and Health Canada audits, particularly for lean teams. The company emphasizes transparency and accessibility in the regulatory space, offering both free information and templates alongside paid consulting services to ensure sustainability and support for startups.
**Expertise & Scope**
* AI-powered eQMS software
* Consulting for EU MDR, FDA, and Health Canada compliance
* Support for lean teams
* Custom regulatory support on a pay-as-you-go basis
* Assistance with medical device classification and certification roadmaps
* Workshops to analyze intended use and classification
* Step-by-step guidance for certification
* Access to Wizard video course and eQMS software
* Expert reviews of documentation
**Reputation / Proof Points**
* Believes healthcare needs fixing, with misaligned incentives and a shady compliance industry.
* Focuses on providing first-class support for startups.
**Expertise & Scope**
* AI-powered eQMS software
* Consulting for EU MDR, FDA, and Health Canada compliance
* Support for lean teams
* Custom regulatory support on a pay-as-you-go basis
* Assistance with medical device classification and certification roadmaps
* Workshops to analyze intended use and classification
* Step-by-step guidance for certification
* Access to Wizard video course and eQMS software
* Expert reviews of documentation
**Reputation / Proof Points**
* Believes healthcare needs fixing, with misaligned incentives and a shady compliance industry.
* Focuses on providing first-class support for startups.
Additional information
OpenRegulatory offers flexible engagement options, including pay-as-you-go custom regulatory support for immediate needs. Their consulting services can help clients solve specific challenges like medical device classification and planning certification roadmaps, providing a written classification assessment. For those seeking a more comprehensive approach, packages include workshops, step-by-step guidance, access to their Wizard video course and eQMS software, and expert documentation reviews. This layered approach allows clients to engage based on their current requirements and budget.
Key Highlights
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Offers 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 for lean teams.
Source
“simplifying EU MDR, FDA, and Health Canada audits for lean teams.”
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Provides custom regulatory support on a pay-as-you-go basis.
Source
“Just take our pay-as-you-go pricing for custom regulatory support.”
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Consulting includes workshops, classification assessments, and certification roadmaps.
Source
“Solve your medical device classification and plan your certification roadmap, including a written classification assessment.”
Certifications & Trust Signals
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Founded on the belief that healthcare needs fixing, aiming to improve transparency and reduce misaligned incentives in the compliance industry.
Source
“We're a group of people who strongly believe that Healthcare needs some fixing. Innovation is slow, incentives are misaligned, and the compliance industry in particular is rather shady.”
Buyer Snapshot
Best for
- Lean teams needing medical device compliance support
- Startups requiring regulatory guidance
- Companies navigating EU MDR, FDA, or Health Canada audits
How engagement typically works
- Pay-as-you-go custom support
- Bundled packages with software and consulting
- Workshops and expert reviews
Typical deliverables
- Written classification assessments
- Certification roadmaps
- Step-by-step to-do lists for certification
- Access to eQMS software and video courses
- Expert documentation reviews
Good to know
- Best when requiring specific guidance on EU MDR, FDA, or Health Canada regulations.
Pricing
Model:
Per project
Public range:
Publicly listed: €250 for two hours of consulting.
Notes:
Based on publicly listed information; final fees depend on scope.
“Two hours with our consultants. Solve your medical device classification and plan your certification roadmap, including a written classification assessment.”
HQ:
Stockholm, DE
Languages:
English
Timezones:
Europe/Stockholm
Claim status:
Listed
Services & Capabilities
Find Importer & Distributor Compliance Providers | Get Quotes
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:
Both
Role Coverage:
Distributor
Additional importer_distributor_compliance Details
Role Coverage
Importer, Distributor, importer, distributor
Supports MDR
Yes
Supports IVDR
No
Verification Support
Yes
Onboarding Steps
Offers workshops to analyze intended use and classification, provides a step-by-step to-do list for certification, includes access to Wizard video course and eQMS software, and offers two expert reviews of documentation.
