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
Estimated TAT: Based on Test
01 - Initial Meeting
Understand Device(s) and agree to scope of project. Client issues Purchase Order.
Understand Device(s) and agree to scope of project. Client issues Purchase Order.
02 - Submit samples to Groenakker for review.
Phase II - Testing
Estimated TAT: Based on Test
Estimated TAT: Based on Test
03 - Groenakker reviews samples & completes sample submission form for client review.
04 - Testing is performed at ISO 17025 accredited laboratory per Groenakker-approved protocols.
Phase III - Data Analysis & Review
Estimated TAT: 2 Days
Estimated TAT: 2 Days
05 - Review of draft test reports for accuracy & conformity to test requirements.
06 - Report correction & finalization.
Phase IV - Reporting
Estimated TAT: 1 Week
Estimated TAT: 1 Week
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.
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.
Available Tests
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.
Sensitization
(ISO 10993-10)
Sensitization
Evaluates the potential of a medical device or its materials to induce an allergic response following exposure.
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
(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.
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.
Implantation
(ISO 10993-6)
Implantation
Evaluates the local biological response of living tissues to medical device materials following implantation.