Ship Faster
Medical Device QMS Software & Consulting
A better workflow for medical device compliance.
We make medical device compliance easy, affordable and transparent. So that startups (like yours) can enter the market and focus on what you do best: Building stuff without getting bogged down by regulations.
We make medical device compliance easy, affordable and transparent. So that startups (like yours) can enter the market and focus on what you do best: Building stuff without getting bogged down by regulations.
Learn. Understand medical device compliance and what it means for your company by reading our free articles and joining free Slack Community.
Write. Create your own medical device documentation with our free templates and eQMS software – and get our consulting to speed things up.
Automate. Dive deeper into our eQMS software to automate your processes and unlock even more time savings.
Trusted by leading medical device manufacturers
Learn
Just starting out? Learn everything you need to know about medical device compliance.
Articles
Free articles to help you understand medical device compliance, written in easy-to-understand human language.
Start reading →Templates
Take a look how medical device documentation actually looks like! The only complete set of free templates on the internet.
View templates →Questions & Answers
Like Stackoverflow, but for medical device compliance - commonly asked questions and our answers to them.
Browse questions →Wizard
Our step-by-step Wizard video course which walks you through creating your own documentation, no prior knowledge required.
Learn more →Write
Create your own medical device documentation in record time and pass your audit.
Formwork
The best eQMS software for lean, agile teams to automate medical device documentation. Better than Jira, Confluence and Sharepoint. Free tier available.
Learn more →Consulting
Work with us to turbo-charge your medical device project: Let us help you to get everything done in weeks, not months.
Learn more →Automate
Ensure continuous compliance and add automation, making you faster than your competitors.
Formwork
AI-enabled, a free set of medical device templates included and free to get started. Export your data any time. It doesn't get better than this. Use Formwork before your competitors will.
Learn more →Lost In Regulation?
Don't worry - you're not alone. We've worked with 150+ companies and are happy to help! Just reach out.