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Compliance, without the complications.

Bring your software to market as a medical device - with our Wizard, articles, free templates and eQMS software.

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Know These Companies?
Now You Know Us.

Ada Health
Alex Therapeutics
AI Body
AI Medical
AIgnostikum
akina
Aury
BabyCare
Better Medicine
deepeye
DeepPsy
Dermadigital
Digitale Healthcare GmbH
DoMore Diagnostics
Ebenbuild
Emergo
Exakt Health
Fimo Health
Floy
Headacy
Healthcaters
iCat
icura
Imvaria
inbiome
Kranus Health
Line Systems
MedxAI
Mindpeak
Molibso
mucoaid
my mhealth
Noah Labs
Nostos Genomics
Novoic
OneTwenty AI
Onqo
Oxaigen
Panakeia
Pathmate Technologies
Perifit
Physikit
PreciPoint
Pregive
Promaton
PulseAI
Radiotherapy AI
Rekoo
Selfapy
SynchroPhi
Tensorscope
Therapy Lift
Tomedo
Una Health
Vara
Vila Health
x-cardiac
Xenco Medical
Zollsoft
Ada Health
Alex Therapeutics
AI Body
AI Medical
AIgnostikum
akina
Aury
BabyCare
Better Medicine
deepeye
DeepPsy
Dermadigital
Digitale Healthcare GmbH
DoMore Diagnostics
Ebenbuild
Emergo
Exakt Health
Fimo Health
Floy
Headacy
Healthcaters
iCat
icura
Imvaria
inbiome
Kranus Health
Line Systems
MedxAI
Mindpeak
Molibso
mucoaid
my mhealth
Noah Labs
Nostos Genomics
Novoic
OneTwenty AI
Onqo
Oxaigen
Panakeia
Pathmate Technologies
Perifit
Physikit
PreciPoint
Pregive
Promaton
PulseAI
Radiotherapy AI
Rekoo
Selfapy
SynchroPhi
Tensorscope
Therapy Lift
Tomedo
Una Health
Vara
Vila Health
x-cardiac
Xenco Medical
Zollsoft

“ As a medical startup, we initially had no knowledge of MDR and the associated regulations. However, the videos, tutorials, and templates from OpenFramework Regulatory were incredibly helpful. They equipped us with the necessary knowledge to implement our processes effectively and successfully achieve the certification (Class IIb). I highly recommend their resources to any startup. Their templates and tutorials are not only informative but also adaptable to specific needs. An excellent resource indeed. ”

Juraj Janak
CEO at S-Case
Case Study #1: Shipping a MDD Class I Device In 3 Months
Case Study #2: Helping pregive ship their app, BabyCare, as a Medical Device

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Who Are We?

We are four dudes who are passionate about making compliance simple and helping Healthcare startups enter the market.

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Recent Updates

Template: Internal Audit Report

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Template: Literature Evaluation Table (MDR Clinical Evaluation)

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How MDD Devices Die: Two Case Studies From The Real World

When it came to regulating medical devices, in the past, we had this old thing which was called the MDD. Under the MDD, a lot of software as a medical device was classified as class I, which meant that manufacturers just had to maintain compliant documentation, without being required to go through an audit before entering the market.

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What Is a Clinical Development Plan?

Question

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Lost In Regulation?

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