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Solutions for Medical Device

Medical Device

Assure QSR compliance and accelerate medical device validation with Kneat

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A top 10 biotech leader

Transforming traceability to improve risk mitigation

The customer, a rapidly expanding biotechnology company with over 45,000 employees achieved an 88% time saving on URS, reducing the cycle time from 2 months...

use cases

  • Commissioning & Qualification Commissioning & Qualification
  • Equipment Validation Equipment Validation

Merck Sharp & Dohme

Merck Sharp & Dohme (MSD) reduced validation time by 50%

MSD digitized seven validation processes globally, reducing cycle times by 50%, process steps by 46%, and replacing three QMS systems.

use cases

  • Analytical Instrument Validation Analytical Instrument Validation
  • Audit Audit
  • Cleaning Validation Cleaning Validation
  • Commissioning & Qualification Commissioning & Qualification
  • Computer System Validation Computer System Validation
  • Equipment Validation Equipment Validation
  • Facilities & Utilities Validation Facilities & Utilities Validation
  • Process Validation Process Validation

Fujirebio Diagnostics, Inc

Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale

Fujirebio Diagnostics cut CAPA change control time in half and is saving 40% on test script execution, translating to significant savings.

use cases

  • Audit Audit
  • Computer System Validation Computer System Validation

Top 10 Pharma Leader

Top 10 pharma leader streamlines CQV

Pharma leader standardized C&Q with Kneat, achieving 20–25% cost savings and 30–40% reduction in validation cycle time.

use cases

  • Analytical Instrument Validation Analytical Instrument Validation
  • Commissioning & Qualification Commissioning & Qualification
Transforming traceability to improve risk mitigation

The customer, a rapidly expanding biotechnology company with over 45,000...

Merck Sharp & Dohme (MSD) reduced validation time by 50%

MSD digitized seven validation processes globally, reducing cycle times by...

Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale

Fujirebio Diagnostics cut CAPA change control time in half and...

Top 10 pharma leader streamlines CQV

Pharma leader standardized C&Q with Kneat, achieving 20–25% cost savings...

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Common Validation Challenges

Solving Medical Device validation challenges

Design validation

Ensuring a medical device meets user needs and intended uses through design validation is critical, as flaws impact patient safety. Kneat centralizes, automates validation, and streamlines technology transfer for efficient compliance and innovation.

Software validation

Medical devices and manufacturing equipment often incorporate software components. Validating software to ensure it performs reliably under all intended conditions is a complex task requiring specialized expertise. Kneat ensures traceable, repeatable testing processes.

Quality system regulations

Adhering to regulations such as the FDA's QSR, which governs the design and manufacturing processes of medical devices, requires meticulous validation of all quality-related aspects. 
Kneat automatically tracks and documents compliance and enables seamless, controlled auditor access.

Suppliers & components

Ensuring suppliers’ components meet specifications is critical, as variability in materials or processes can impact device quality. Kneat streamlines supplier validation by centralizing supplier audit, material inspections, and verification testing, minimizing the risk of failure or recall.

It’s what I really wanted, the ability to still author and execute in the traditional manner, but not having the ‘on paper’ anymore.

Manager IT Compliance, Fujirebio Diagnostics, Inc

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Industry Solutions

Elevating validation for Life Sciences

We are built for biotechnology, pharmaceuticals, medical devices, and consumer health.

Solutions by industry

Accelerate release to production and ensure customer confidence with more efficient, transparent documentation. Perform technology transfer and meet deadlines faster and easier.

Overcome complexity across process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations.

Get more products to market faster without compromising quality. Improve the efficiency of the entire validation lifecycle for all your consumer health products.

Our expert team and industry-leading solution help pharma quality assurance and validation teams overcome compliance and operational challenges every day.

Revolutionize your validation

Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.

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