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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 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 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
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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Articles

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Questions answered

83

Free Templates

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Consulting Customers

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eQMS Users

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Community Members

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

Free QMS Software: Google Drive, SharePoint, GitHub, GitLab And Others

So your company works in a regulated industry (like medical devices, what we specialize in) and you have to set up a Quality Management System (QMS) for compliance reasons. Great. And now you’re looking for QMS software so that you can get it done more efficiently. I often get asked whether there’s any free QMS software out there.

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ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes

KPIs are like scorecards for organizations, helping them track how well they’re doing and if they’re moving closer to their goals. In the world of ISO 13485 (Section 4.1.3 and Section 8.2.5), process KPIs are important to be compliant. They are the metrics by which the health of our processes is measured.

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Template: SOP Machine Learning Model Development (AI)

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Template: Instructions On Data Annotation (Machine Learning / AI)

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Lost In Regulation?

Don't worry - you're not alone.
Take a look at how you can get your compliance done efficiently.

Need help?
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