When a medical device comes into contact with the human body, absolute safety is non-negotiable. Even the most advanced device can fail regulatory scrutiny if its materials induce toxic, allergic, or inflammatory responses in patients.
Qualitech International provides end-to-end biological evaluation services. We meticulously analyze your device materials according to ISO 10993 standards, executing both in-vitro and in-vivo testing to generate the undeniable safety data required by Notified Bodies and the FDA.
De-risking Patient Interaction
We guide you through the complex matrix of biocompatibility requirements, ensuring you only perform the necessary tests to prove safety without wasting time or resources.
- Biological Evaluation Plans (BEP) and Reports (BER).
- Full compliance with the ISO 10993 series and FDA guidelines.
- Chemical characterization (Extractables & Leachables).
- Cytotoxicity, Sensitization, and Irritation testing.
- Expert toxicological risk assessments.
What We Offer ?
Identify and quantify extractables and leachables (ISO 10993-18) to understand the chemical profile of your device before biological testing.
Rapid and highly sensitive in-vitro cell culture testing (ISO 10993-5) to determine if your device materials cause cell death or damage.
Assess the potential of your device materials to cause delayed allergic reactions or localized skin/tissue irritation (ISO 10993-10 & 23).
Evaluate the effects of blood-contacting devices on red blood cells, coagulation, and thrombosis (ISO 10993-4).
Conduct acute, subacute, subchronic, and chronic toxicity testing (ISO 10993-11) to evaluate broader physiological impacts.
Our board-certified toxicologists evaluate the chemical characterization data to potentially waive unnecessary animal testing and save costs.
Why Choose Qualitech International ?
Smart Testing Strategies
We write intelligent Biological Evaluation Plans (BEP) that leverage existing data to minimize redundant testing and reduce costs.
Global Acceptance
Our testing is conducted in GLP-certified laboratories, ensuring your biocompatibility data is universally accepted by the FDA, EMA, and Notified Bodies.
Expert Toxicologists
Our team includes seasoned toxicologists who can interpret complex chemical data and defend your safety rationale to regulators.
Frequently Asked Questions
Have questions about regulatory compliance, market access, or our services?
Here are answers to the most common inquiries from Medical Device and IVD manufacturers.
Do I need to perform all tests listed in ISO 10993?
No. The required tests depend entirely on the nature of body contact and the duration of contact. We will create a specific Biological Evaluation Plan (BEP) to determine exactly which tests are mandatory for your device.
Can chemical characterization replace biological testing?
In many cases, yes. A robust chemical characterization (ISO 10993-18) combined with a Toxicological Risk Assessment (TRA) can often justify waiving expensive and time-consuming systemic toxicity or genotoxicity tests.
How long does biocompatibility testing take?
Timelines vary significantly. Cytotoxicity can take just a few weeks, while chronic toxicity or long-term implantation studies can take several months.
