Tired of Manual Paper Documentation?

Get eSignatures and Automated Workflows in a Ready-to-Use Validated eQMS for Life Science.

FDA 21 CFR Part 11

GxP Compliant

ISO 13485:2016


FDA 21 CFR Part 820

ISO 9001:2015

eQMS for

Medical Devices


✓ ISO 13485:2016 Certified

✓ EU MDR Ready

✓ Efficient Document & Design Control

eQMS for



✓ GxP Compliant & Validated

✓ Efficient Training Management

✓ Easy Deviation & CAPA Tracking

What We Offer

Ready to Use

Get started quickly with Pre-Validated Workflows built for Life Science Companies. You will save time with our proven implementation method which takes down to 5 weeks.


Ensure that your employees master your eQMS. You will get the needed skills through extensive hands-on training. We certify your employees in all processes related to their job role.

Life Sciences Specialists

Reduce your risk by working with our Life Science Specialists, with more than 30 years of experience implementing validated software. We ensure that your eQMS is audit-ready at any time.

21 CFR Part 11 Compliant eSignatures

SimplerQMS enables you to sign any record with our Part 11 Compliant eSignatures. Automated workflows and notifications allows for a seamless and fully digitized process – supporting both internal and external users.

Our Clients

How Did Reapplix Move From Paper in 1 Month?

Reapplix is a regenerative medicine company that helps people who suffer from hard to heal diabetic foot ulcers, which may result in amputation. The company is in the initial commercialization phase in the US and selected European markets and was looking for a way to get rid of inefficient paper-based documentation and processes.

What People Are Saying

The collaboration with SimplerQMS has lived up to our expectations. Their service has been superb and very supportive.

Niels Erik Holm

COO, Reapplix

During the implementation of SimplerQMS, the expectations of SimplerQMS’s team have been exceeded. We have got a lot of help – also at awkward hours of the day.

Louise Flintegaard Ehlert

QA Process Manager, Cortrium