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Meet ISO 13485 and 21 CFR part 820 requirements and accelerate time to market

Align quality assurance and product development workflows, ensuring complete traceability with Scilife smart QMS for Medical Devices.
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  • Logo of Scilife customer Biocartis, user of Scilife QMS for Medical Devices | Scilife
  • Logo of Scilife customer Amnovis, user of Scilife QMS for Medical Devices | Scilife
  • Logo of Scilife customer Shoebox, user of Scilife QMS for Medical Devices | Scilife
  • Logo of Scilife customer Novosanis, user of Scilife QMS for Medical Devices | Scilife
  • Logo of Scilife customer Olfactomics, user of Scilife QMS for Medical Devices | Scilife
  • Logo of Scilife customer Caristo, user of Scilife QMS for Medical Devices | Scilife
  • Logo of Scilife customer Midiagnostics, user of Scilife QMS for Medical Devices | Scilife

All your medical device design controls centralized in one space

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Challenge

 

Medical device companies often manage quality with multiple, unconnected systems, leading to a fragmented approach.

These non-scalable systems make it hard to keep development and quality teams aligned and adapt to new regulations and market demands as companies grow.

Image that represents the benefits of implementing a design control software for Medical Device | Scilife

Solution

 

Accelerate product development and ensure seamless design control with Scilife Smart QMS for medical devices.

Gain full oversight with an automated traceability matrix, version control, and compliant electronic signatures—ensuring regulatory compliance while streamlining workflows.

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Complete toolset

Manage your medical device by leveraging other Scilife tools like Documents, Records, Events, CAPAs, and Change Control.

Icon that represents a traceability matrix of a design control software for medical devices | Scilife

Streamlined compliance

Ensure ISO 13485:2016 and FDA 21 CFR 820 compliance with proper approvals using 21 CFR Part 11 electronic signatures.
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Automated traceability matrix

Spot gaps in requirements effortlessly with an auto-generated audit trail.

Simplified design and development process:


  • Don’t let design controls documenting slow you down; trace your design controls effortlessly and find gaps in the traceability matrix with just one click.
  • Reduce time-to-market with a simplified approval cascade. 
Screenshot that shows the approval cascade of a design control software for medical devices | Scilife

Clear and comprehensive traceability at every stage:


  • Link design controls with user needs, assess the impact of every change on validation, and easily track testing and verification.
  • Provide detailed project oversight to all involved teams and boost visibility and collaboration. 
Screenshot that shows how a design control software for medical devices ensures full traceability | Scilife

Improved version control:


  • Analyze project changes at first glance comparing prior versions of the product with the current one.
  • Assess the evolution of the project and provide valuable insights during audits. 
Screenshot that shows the version comparison tool of a design control software for medical devices | Scilife

Exciting updates ahead!

Our latest Design and Development solution is set to launch soon!"

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Turn quality into your brightest asset with Scilife

When we embrace quality, brilliant things happen!
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