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Smart Quality Management System for Medical Devices & IVD

Forget about recalls and traceability issues with Scilife QMS Software

Implement a Total Product Lifecycle approach, digitize all your data and processes,
and bring to market safe and compliant high-quality Medical Devices

Book your Demo

What a Smart QMS can do for you


Implement an agile risk mitigation strategy with Scilife Quality Management System for Medical Devices | Scilife

Avoid recalls, put quality at the center

Quality needs to be the main focus: Implement an agile risk mitigation strategy with a smart quality platform and prevent recalls and health issues.

Start the digitalization process with Scilife Quality Management System for Medical Devices | Scilife

Start your digital transformation journey

Adapting to the latest technology trends is crucial to ensuring product quality, reducing costs, improving efficiency, and complying with global regulations. Start by implementing a smart quality platform!

Improve your quality traceability with Scilife Quality Management System for Medical Devices | Scilife

Closed-loop quality traceability is
the way to go!

Improve your quality traceability by adopting a total product lifecycle approach, making updated data and processes available to everyone, and fostering continuous improvement.

Where All Your Quality Comes Together


Popular Features

Design & Development

  • Integrated Risk Assessment
  • Automated Traceability Matrix

Processes with configurable workflows

  • Supplier Management

Advanced Analytics

Print & Reconciliation

Other features

  • Full validation documentation package (GAMP5)
  • Audit Trail
  • User tasks list
  • Personalized training
  • 1 : 1 Technical Support

Here’s where Scilife can help you

We are QA’s performance-boosting allies

Amanda Amell's picture, quality assurance associate at Shoebox | Scilife
Shoebox audiometry logo as Scilife Medical Device customer

‘A paper-based QMS is a major pain point for anyone. Having to do manual signoffs, maintaining paperwork, tracking missing updates, documents or trainings is a whole lot more time consuming. We used to pass paper along different people's desks and have to wait. With paper in general, there are associated risks.’

Amanda Amell,
Quality Assurance Associate at SHOEBOX
Surgery team working to illustrate Antti Roine's quote, CEO of Olfactomics | Scilife
Olfactomics logo as Scilife customer

‘I think Scilife is the best product in the market [...] it is actively developed, and its pricing model is scalable and well suited for start-ups. We built our ISO 13485 QMS on Scilife platform from scratch and have been very happy with it.’

Antti Roine,
CEO of Olfactomics

Do you need a hand in improving your traceability and avoiding product recalls?

Let's have a chat to find a QMS solution just for you!
Book your Demo

High Performer Medical QMS on G2

Customers rated Scilife a High Performer Medical QMS in the G2 Summer 2022 report.

This ranking system considers both user satisfaction and market presence of the software, compared to similar products, placing Scilife in the “High Performer” quadrant of the G2 Grid®.

Scilife rated as High Performer QMS Software for Medical Devices in G2 | Scilife
Scilife rated with Best Relationship QMS Software for Medical Devices in G2 | Scilife
Illustration of 3 hands creating a fask shape to encourage Pharma & Biotech industry companies to get in touch with Scilife
Illustration of 2 hands building a SaaS interface to encourage Medical Devices & IVD companies to request Scilife's price.
Illustration of a rocket-microscope taking off to encourage Medical Devices companies to book a Scilife demo.