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Medical Device Testing
Why Test Medical Devices ?
With technology evolving rapidly, the innovation in the medical devices sector has become huge. Industries, individuals and entrepreneurs are finding new ways to develop devices that help accelerate treatments and aid in disease diagnosis. As newer products arrive, there’s an increased need for laboratories where medical devices are tested for several chemical and biological parameters and deemed safe to be employed in clinical use.
We Test Medical Devices For You
Whether it is navigating complex regulatory scenarios, managing budgets and time constraints, or helping you build devices that alleviate the suffering and pain of patients, we can aid you with our testing and consultation services. We test your devices using customized experimental designs and assist you in ensuring that any risks due to the use of your product are minimal.
Our ISO Certification and 30+ years of combined experience speak for the work we do.
Our Medical Device Testing Services
- Bioburden Testing
- Microbial Ingress Test
- Bacterial Endotoxin Testing Sterility Testing
- Custom Medical Device Studios
- Medical Devices Cleaning Validation
- Bacterial Endotoxins Method Validations
- Chemical Indicators Evaluation
- Antimicrobial Efficacy Testing for Wound Dressings
- Sterility Method Validations
- Cleanroom Microbiological Environmental Monitoring and Qualifications Programs
- Bioburden Method Validations
- Biological Indicators Evaluation and Enumeration
- Stasis Test
Bioburden Medical Devices Testing
Bioburden testing is represented by USP 60, USP 61, USP 62, and USP 1111. Nonetheless, USP 60-USP 62 are the essential directions followed for bioburden testing. Film filtration, pour-plate, surface-spread, and most-plausible number procedures are the foundation strategies utilized for bioburden testing.
Methods that we follow:
- Membrane Filtration Method
- Most-Probable-Number Method
- Pour-Plate Method
- Surface-Spread Method
Priority Medical Device Project, WHO has created a list of priority medical devices that are necessary to counter diseases like cancer and covid-19. This devices help to support quality of care, increase health safety and assist health care infrastructures.
No. 24, 22nd Main, Marenahalli,
J P Nagar 2nd Phase, Bengaluru
J P Nagar 2nd Phase, Bengaluru