Qualification & Validation

As a key player in high-value-added plastic injection, CLAYENS Healthcare offers comprehensive and tailor-made support to healthcare stakeholders, from the design of their device to its production, in accordance with international regulatory requirements.

Deprecated function: parse_str(): Passing null to parameter #1 ($string) of type string is deprecated in Drupal\redirect\EventSubscriber\RedirectRequestSubscriber->onKernelRequestCheckRedirect() (line 125 of modules/distrib_sequentiel/redirect/src/EventSubscriber/RedirectRequestSubscriber.php).
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Deprecated function: Return type of Drupal\bootstrap\Utility\Storage::valid() should either be compatible with Iterator::valid(): bool, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in include() (line 28 of themes/bootstrap/src/Utility/Storage.php).
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Deprecated function: Drupal\bootstrap\Utility\Attributes implements the Serializable interface, which is deprecated. Implement __serialize() and __unserialize() instead (or in addition, if support for old PHP versions is necessary) in include() (line 576 of vendor/composer/ClassLoader.php).
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Qualification & Validation

Process validation :

FOT (first of tool)
SAT (Site Acceptance test)
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)

Product validation :

Functional product validation
Shelf life validation
Transport validation
Biocompatibility testing (subcontracted)

Regulatory Affairs :

Regulatory monitoring
Support for technical documentation and CE registration
Support for FDA registration

End-to-end support: Qualification & Validation

Our products are developed and manufactured in compliance with international Health standards (ISO 13485, ISO 15378, FDA 21 CFR part 820).

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