BREAKING: Groenakker Achieves ISO 13485:2016 for Advisory & Test Subcontracting Services

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Test SubContracting

Groenakker offers a full suite of in vitro and in vivo services through qualified partners. We routinely assist clients by leveraging our global testing network to provide high-quality testing at industry-leading prices and turn around times. The most common studies which we support are available within the Shop, though through our partners we have access to the full complement of biocompatibility tests associated with ISO 10993 and ISO 18562.

How it works

Phase I - Planning & Review
Estimated TAT: Based on Test
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01 - Initial Meeting
Understand Device(s) and agree to scope of project. Client issues Purchase Order.
 
Submit Samples Icon
02 - Submit samples to Groenakker for review.
 
Phase II - Testing
Estimated TAT: Based on Test
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03 - Groenakker reviews samples & completes sample submission form for client review.
 
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04 - Testing is performed at ISO 17025 accredited laboratory per Groenakker-approved protocols.
 
Phase III - Data Analysis & Review
Estimated TAT: 2 Days
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05 - Review of draft test reports for accuracy & conformity to test requirements.
 
Report Correction Icon
06 - Report correction & finalization.
 
Phase IV - Reporting
Estimated TAT: 1 Week
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07 - Final approved reporting of results to Client.
Test Sourcing
ISO 13485:2016 Quality Management System
We identify, qualify, and manage competent laboratory service providers so you don't have to.

Groenakker partners with ISO 17025 laboratory testing partners around the world to provide the best services at competitive prices and turnaround times. Along with chemistry and toxicology services provided through our ChemTox™ program, routinely subcontracted studies are listed below. If you do not see what you're looking for contact us today for a custom estimate.
ISO 13485:2016 Certificate
Available Tests
Cytotoxicity icon

Cytotoxicity

(ISO 10993-5)

Cytotoxicity

Assesses the potential of a medical device material or extract to cause cell damage or death through in vitro cell culture testing.
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Sensitization

(ISO 10993-10)

Sensitization

Evaluates the potential of a medical device or its materials to induce an allergic response following exposure.
Irritation icon

Irritation

(ISO 10993-23)

Irritation

Assesses the potential of medical devices and their materials to cause local irritation at the site of contact.
Systemic Toxicity icon

Systemic Toxicity

(ISO 10993-11)

Systemic Toxicity

Examines the potential for systemic adverse effects resulting from exposure to medical device materials or their extracts throughout the body.
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Haemocompatibility

(ISO 10993-4)

Haemocompatibility

Evaluates the interactions between medical device materials and blood to identify risks such as thrombosis, hemolysis, or adverse effects on blood components.
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Implantation

(ISO 10993-6)

Implantation

Evaluates the local biological response of living tissues to medical device materials following implantation.