OpenRegulatory
Company profile
Company Overview
OpenRegulatory is dedicated to simplifying medical device compliance and helping healthcare startups bring their products to market faster. They offer a workflow solution focused on making medical device compliance easy, affordable, and transparent, allowing startups to focus on product development without being bogged down by regulatory challenges.
Their services include:
- Consulting services to assist healthcare startups with medical device certification and compliance.
- An advanced eQMS (electronic Quality Management System) software called Formwork, designed for lean and agile teams to automate medical device documentation and processes.
- Free educational resources, templates, and a Wizard video course for creating compliant medical device documentation.
- Ongoing compliance automation to help maintain certification and improve efficiency.
OpenRegulatory is bootstrapped, profitable, and focused on serving healthcare startups with realistic, specialized solutions. Their team consists of professionals passionate about compliance and healthcare innovation, with advisors who bring expert knowledge in medical and AI fields.
Work Culture and Values
The company emphasizes a healthy work-life balance, offering a four-day workweek, minimal meetings, and autonomy in work hours and goals. They encourage productivity over long hours and provide profit-sharing bonuses akin to freelancer compensation. OpenRegulatory fosters a respectful environment without micromanagement, favors asynchronous communication over constant messaging, and values sustainable, customer-focused product development.
Job Opportunities
OpenRegulatory currently lists their open positions on a dedicated external job board for Digital Health Jobs. Interested candidates can view open roles via https://digital-health-jobs.com/companies/1.
