Validated eQMS platform for regulated life science companies
SimplerQMS builds a pre-validated quality management system purpose-built for life science and medical device companies navigating GxP, FDA, and EU regulatory frameworks. The tech stack (TypeScript + Rails + PostgreSQL on AWS) is lean and focused; notably absent are modern data-warehousing or BI tools, despite active projects around forecasting, BI platform development, and SaaS metrics reporting—suggesting data infrastructure is a current bottleneck as the company scales internationally. Sales velocity is accelerating with 11 open roles across seven departments, but pain-point clustering around pipeline accuracy, data hygiene, and international expansion signals the org is outgrowing its current operational backbone.
SimplerQMS is a Danish eQMS vendor serving mid-market life science, pharma, and medical device companies. The platform is fully validated for compliance with GxP, ISO 13485:2016, FDA 21 CFR Parts 820 and 11, EU GMP Annex 11, and EU MDR/IVDR—eliminating the validation burden from customers. The company combines software with regulatory expertise and customer success partnerships to help teams streamline quality processes, reduce manual work, and lower compliance costs. Founded in 2017, SimplerQMS operates with 51–200 employees based in Copenhagen and is actively expanding its sales, support, and product teams across multiple geographies.
SimplerQMS runs on TypeScript and Ruby on Rails backed by PostgreSQL, hosted on AWS. The frontend is built with Svelte. Code is managed on GitHub.
SimplerQMS is headquartered in Copenhagen, Denmark. It is actively hiring across Denmark, Belgium, Philippines, United States, and Syria.
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