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Smart QMS

Transform quality into your brightest asset

Smart QMS for Medical Devices

Accelerate from idea to market for medical devices

Controlled Printing and Reconciliation

21 CFR 11 compliant controlled printing

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Document Management

Ensure a digitalized, quality-driven approach

Quality Events Management

Reduce compliance issues and save time

Change Control Management

Implement change faster

Risk Management

Take away the dread and reduce the risks

Quality KPIs

Enhance performance with quality metrics

Training Management

Boost continuous learning

CAPA Management

Streamline workflows to instill a quality culture

Audits Management

Remove stress and simplify compliance

Equipment Management

Ensure consistent maintenance
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Pharma and Biotech

Integrate and automate all your quality process

Medical Devices

Bring safe and compliant devices to market faster

Medicinal Cannabis

Boost efficiency to breeze through trial deadlines

CRO/CMO

Boost efficiency to breeze through trial deadlines

ATMP

Track all your manufacturing process

Use cases

Building a GMP-compliance QMS

Ensure quality and safety in all your products

Becoming audit ready

Stay audit-ready stress-free anytime

Streamline Design Control process

Ensure full traceability in your Medical Device

Complying with GDP standards

Safeguard your supply chain with GDP compliance

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Master the essential soft skills for a quality-driven life sciences team

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2025 Global Quality Outlook

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The Full Guide to QMS in Pharma

From QMS basics and regulations to implementation, learn everything about managing a quality management system >>
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QMS software for Medical Devices

Smart Quality Management Software according to ISO 13485 and 21 CFR part 820

Manage the whole Medical Device design control and product development process according to strict compliance regulations and bring your medical device to market faster.

Medical Device seeding control and product development software | Scilife

Are your design and development processes slowing you down?

Bringing a medical device to market is a long and challenging process. There are multiple stages of design and development to navigate, as well as validation, before obtaining regulatory approval. And when human errors occur or documents go missing, this causes significant delays.

Creative illustration featuring a medical device box sprouting flowers.This artwork highlights how design control in the medical device development process can improve lives and foster innovation in healthcare | Scilife

Streamline whole process

Enhance workflow clarity and streamline your design and development process from inception to launch so that you can accelerate to market. Benefit from an intuitive visualization of the entire approval cascade for each process workflow. If you are a medical device company and need fast, efficient regulatory lifecycle management, the Scilife Design and Development solution is for you.

Screenshot showing details about the design control workflow and medical device product development process | Scilife

Ensure full traceability

Effortlessly navigate your design and development process.

Our traceability matrix allows you to connect design inputs with user needs, evaluate the impact of changes on validation, and track testing and verification steps with ease. Quickly filter and address unlinked items and traceability gaps, ensuring comprehensive oversight and streamlined project management.

Screenshot showing details about the traceability matrix and medical device product development process | Scilife

Version comparison tool

Enhance your traceability capabilities with our comparison tool. This feature empowers users to further streamline traceability by comparing project changes between prior versions and the current one. Such a tool is invaluable in assessing the evolution and progress of a project, especially during audits.