Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Avoiding unreasonable reliance on subcontractor certification.

M E Donawa1

  • 1Donawa and Associates Ltd, Rome, Italy. donawa@srd.it

Medical Device Technology
|May 27, 1999
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

New FDA draft guidance on premarket submissions.

Medical device technology·2000
Same author

The quality planning conundrum.

Medical device technology·2000
Same author

Drug delivery: the strategic advantage of design controls.

Medical device technology·1999
Same author

Use and recognition of consensus standards in US premarket submissions.

Medical device technology·1999
Same author

An improved draft guidance to process validation.

Medical device technology·1999
Same author

Notifying the competent authorities.

Medical device technology·1999
Same journal

Safer arterial access.

Medical device technology·2010
Same journal

Building better surfaces.

Medical device technology·2010
Same journal

PVC: a broader perspective.

Medical device technology·2010
Same journal

Joining and forming using torsional ultrasonic principles.

Medical device technology·2010
Same journal

US regulation of combination products.

Medical device technology·2010
Same journal

Assessing biological safety of metals associated with medical devices.

Medical device technology·2010
See all related articles

Device manufacturers increasingly rely on subcontractor quality system certification. However, over-reliance on this certification in assessments poses significant risks that warrant careful consideration.

Area of Science:

  • Quality Management Systems
  • Medical Device Manufacturing
  • Supply Chain Risk Management

Background:

  • Subcontractors providing products/services to device manufacturers are increasingly obtaining quality system certification.
  • This trend aims to improve product and service quality within the medical device supply chain.
  • However, current manufacturer assessment practices may overly depend on this certification alone.

Purpose of the Study:

  • To critically evaluate the practice of device manufacturers placing excessive reliance on subcontractor quality system certification.
  • To identify and discuss the potential dangers associated with this over-reliance in subcontractor assessment programs.

Main Methods:

  • Qualitative analysis of current industry practices in subcontractor assessment.

Related Experiment Videos

  • Review of potential failure modes when certification is the sole criterion.
  • Discussion of case examples illustrating risks of over-reliance.

    • Main Results:

    • Over-reliance on quality system certification can create a false sense of security.
    • It may lead to the neglect of other critical supplier evaluation factors.
    • Potential for undetected product or service deficiencies despite certification.

    Conclusions:

    • While quality system certification is valuable, it should not be the sole determinant in subcontractor assessment.
    • Manufacturers must adopt a comprehensive, risk-based approach to subcontractor evaluation.
    • A balanced assessment strategy is crucial for ensuring medical device quality and patient safety.