Medical

Superior Quality Assurance for Medical Device Manufacturing

Process Signature Verification provides the most detailed monitoring of your process possible.

A major medical device manufacturer used Sciemetric's PSV technology to build a case for the elimination of destructive pull tests on their welding process.

Science-level analysis is brought directly into the medical device manufacturing plant and leads to the following benefits:

  •  Objective proof of process compliance with specifications
  •  100% verification of your medical device against known failure modes
  •  Reduced recalls through post-shipment reanalysis
  •  Reduced validation times
  •  Parametric release for reduced visual inspections 

What is Process Signature Verification?

Process Signature Verification uses the change of physical parameters during a (manufacturing) process, to indicate the success or failure of that process, resulting in a 100% quality verification. In addition, Process Signature Verification also produces 100% process documentation and a parametric guide to root cause determination.

A process signature is a detailed description of the behavior of the physical parameters of a manufacturing process, such as force and distance in an assembly press operation.

Where can you use Process Signature Verification?

Many medical device manufacturing processes and quality tests can benefit from the insight generated by Sciemetric. The physical variables it measures and the calculated values it produces provide detailed information into the manufacturing processes. For instance, calculated 'work done' is often used to shorten verification time in press operations.


Download the datasheet on Sciemetric's Process Signature Verification for medical devices.


Results of Signature Verification

  • Reduced Warranty and Recall

    A leading cardiac device manufacturer used Sciemetric equipment to eliminate destructive testing and realize significant reduction in product scrap.


    Sciemetric reduced a powertrain recall from 10,000 to 7 units through post-shipment analysis of the signature data.
  • Increase Yield
    Sciemetric's technology reduced failures on vacuum pump manufacturing by 98% (savings of $4.8 million a year) by identifying 2 different failure behaviors, one of which could be handled by new specifications on an internal part.
  • Accelerated Line Launch
  • Accelerated launch by 400% for global automotive company due to insight into process
  • Accelerated Process Validation
  • Assembly process validation accelerated through signature curve documentation

SCIEMETRIC ARTICLES

Process Signature Technology Helps Manufacturers Apply Risk Management in a Tough Regulatory Environment
Medical device companies are facing pressure from regulatory bodies to place greater emphasis on improving manufacturing quality and risk management.
MDD, September 2009

Design of Experiments with Process Signature Verification
Process signature verification is a technique that is new to many medical device companies. Here is how to do it.
MD&DI, January 2007

Signature Analysis: Applying R&D Science to the Manufacturing Plant
Describes the science that gives insight to the successful manufacture of medical devices.
Focus, the publication for the Association of British Healthcare Industries (ABHI), April 2006

Process Signature Verification for Medical Device Manufacturing
How Process Signature Verification enables manufacturers to identify the root cause of failures.Medical Device & Diagnostic Industry (MD&DI), September 2005