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, aiming to simplify audits for lean teams. They specialize in navigating complex regulatory landscapes such as EU MDR, FDA, and Health Canada requirements.

**Expertise & Scope**
* Offers AI-powered eQMS software.
* Provides consulting services for medical device compliance.
* Focuses on simplifying EU MDR, FDA, and Health Canada audits.
* Supports lean teams in regulatory compliance.
* Offers pay-as-you-go custom regulatory support.
* Provides workshops to analyze intended use and classification.
* Delivers step-by-step to-do lists for certification.
* Includes access to a Wizard video course and eQMS software.
* Conducts 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 models, including pay-as-you-go options for custom regulatory support. Their services can help clients solve specific challenges like medical device classification and planning certification roadmaps. They provide a written classification assessment as part of their offerings. For those not ready to commit, their custom support allows for targeted assistance. They also offer a workshop to analyze intended use and classification, followed by a detailed to-do list for certification. Access to their Wizard video course and eQMS software is included in some packages, alongside expert reviews to ensure documentation is on the right track.

Key Highlights

  • Offers AI-powered eQMS software and consulting for medical device compliance. Source
    “OpenRegulatory offers AI-powered eQMS software and consulting for medical device compliance”
  • Simplifies EU MDR, FDA, and Health Canada audits for lean teams. Source
    “simplifying EU MDR, FDA, and Health Canada audits for lean teams.”
  • Provides custom regulatory support on a pay-as-you-go basis. Source
    “Just take our pay-as-you-go pricing for custom regulatory support.”
  • Offers workshops to analyze intended use and classification, including a written assessment. Source
    “We'll help you get started with a workshop in which we analyze your intended use and classification. ...including a written classification assessment.”

Certifications & Trust Signals

  • Focuses on providing first-class support for startups. Source
    “This allows us to stay true to our goal of providing first-class support for startups.”
  • Aims to make the regulatory space more transparent and accessible. Source
    “While we're committed to providing as much free information and templates as possible to make the regulatory space more transparent and accessible to all”

Buyer Snapshot

Best for
  • Startups needing regulatory compliance support
  • Lean teams managing medical device audits
How engagement typically works
  • Pay-as-you-go custom support
  • Workshop-based analysis and planning
  • Consulting services
Typical deliverables
  • AI-powered eQMS software access
  • Written classification assessment
  • Certification roadmap planning
  • Step-by-step certification to-do list
  • Expert documentation reviews
Good to know
  • Best when requiring support for EU MDR, FDA, and Health Canada regulations.

Pricing

Model: Per project
Public range: Publicly listed: €250 for two hours of consultant time.
Notes: Pricing is based on publicly listed information for specific services like two hours of consultant time.
“Two hours with our consultants. Solve your medical device classification and plan your certification roadmap, including a written classification assessment. Pricing: Price 250; €”
HQ: Stockholm, DE
Languages: English
Timezones: Europe/Stockholm
Claim 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: 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, and includes expert reviews of documentation.
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