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Incoming Medical Devices Laboratory
Test Requests
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No. |
Medical Devices Testing or
medical devices Description |
status |
| 10-02161 |
CHINA SFDA,FDA,GLP,USP,ASTM,ISO Preclinical Contract Research Organization needed to test the biocompatibility for medical devices such as stent or blood pooling bag. (
read more )..... | |
| 10-02047 |
USA ISO Laboratory needed for fifteen samples of medical devices to be tested for phthalate in support of CE Mark. (
read more )..... | |
| 10-02022 |
USA/India FDA GMP/GLP Preclinical Contract Research Organization needed for in-vitro drug release analysis of medical device, Stability Studies for medical devices, Sample as required for testing. (
read more )..... | |
| 10-01792 |
Australia/USA GLP Laboratory needed for cytotoxicity testing of medical devices, contact lens. Agar overlay and direct contact. Must be GLP certified for regulatory body, TGA, CE mark (
read more )..... | Closed |
| 10-01462 |
Pakistan ISO Bioanalytical Laboratory needed for bio-mechanical, bio-compatibility certificate in accordance to the article Regulation of Medical Devices as published by the General Directorate of the Ministry of Health. (
read more )..... | |
| 10-00916 |
Materials Laboratory needed for testing dozen different coatings we apply to medical devices. What we want tested is having the parts that are coated gamma sterilized. Our purpose is to determine if the different coatings react differently to gamma radiation.
(
read more )..... | |
| 10-00383 |
Vancouver Bioanalytical Laboratory needed for spore testing on an autoclave. (
read more )..... | |
| 10-00334 |
Australia and Asia ISO 17025 Analytical Chemistry testing Laboratories needed for ETO residual testing in medical devices. Our laboratory is applying for ISO 17025 accreditation. We need to send samples to compare results. (
read more )..... | Closed |
| 10-00331 |
USA FDA GLP Physical Histology Laboratory needed for side by side comparison of cardiovascular devices testing against a predicate to substantiate equivalency claims for labeling.
Various models and analysis. (
read more )..... | Closed |
| 10-00162 |
Microbiology Laboratory needed for ASTM Testing, ASTM F1714-96(2008) and Sterilization test for medical devices?
(
read more )..... | |
| 10-00009 |
Canada Medical Device Microbiology Laboratory needed to validate manufacturer's reprocessing instructions for a medical device in accordance with Canadian Standard CSA-Z17664-06 "Sterilization of medical devices- Information to be provided by the manufacturer for the processing of resterilizable medical devices" (
read more )..... | Closed |
| 09-2531 |
India Toxicology Laboratory needed for Biocompatibility testing of medical devices, cytotocicity, irritation, sensitization (
read more )..... | Closed |
| 09-2452 |
Analytical Chemistry Laboratory needed for ISO 10993 EO residual testing from medical devices (
read more )..... | Closed |
| 09-2391 |
USA FDA GLP Materials Laboratory needed for SEM analysis of explanted medical devices (surface analysis for degradation and infiltration) (
read more )..... | Closed |
| 09-2321 |
Australia, USA or UK ISO Toxicology Laboratory needed for ISO Cytotoxiity Testing or food grade HDPE tubing to be tested as per ISO10993.1 for external communicating device - circulating blood with less than 24hour(limited) contact. (
read more )..... | |
| 09-2251 |
USA FDA GMP Medical Devices Laboratory needed for Accelerated Aging Stability Studies. (
read more )..... | Closed |
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As a company, we produce orthopaedical medical devices. We want some of our plates and screws to be exposed to mechanical tests (like static test)
(
read more )..... | Closed |
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As a company, we produce orthopaedical medical devices. We want some of our plates and screws to be exposed to mechanical tests (like static test)
(
read more )..... | Closed |
| 09-1857 |
Australia/Europe/Asia Preclinical Contract Research Organization needed for Medical Devices Biocompatibility Sensitization as per ISO 10993-10 and Cytotoxicity agar overlay method (
read more )..... | Closed |
| 09-1746 |
FDA 510(k) Preclinical Contract Research Organization required for:
Medical Device Design and Modelling of Systems
Medical Device Compliance Testing
Reuseable Medical Devices Testing
Medical Devices Methods Development and Validation Testing
Medical Devices Transportation Simulation Studies
Need estimates within the week for budget deadline.
(
read more )..... | |
| 09-1744 |
FDA 510(k, GLP, ISO, ASTM Bioanalytical and Microbiology Laboratory needed for the following:
Medical Device Sterility Testing
Medical Devices Microbiology Testing
Medical Device Microbial Identifications Testing
Medical Device USP Microbial Limits Testing
Medical Device USP, AAMI, EP Bacteriostasis/Fungistasis Testing
Medical Device Product Inoculations Testing
Medical Device Bioburden Testing
Total Fungi Testing
Total Aerobes Testing
Total Coliforms Testing
Ethylene Oxide (
read more )..... | |
| 09-1743 |
FDA GLP, ISO, ASTM Preclinical Contract Research Organization needed for:
Medical Device Stability Studies Testing
Medical Devices Accelerated Aging Stability Studies.
Medical Devices Real Time Stability Studies.
Need estimates within 1 week for budget deadline
(
read more )..... | |
| 09-1742 |
FDA GMP Medical Packaging Laboratory required -
Need estimates for Budget in the within the next week.
Medical Devices Packaging Studies and Testing.
Medical Device Package Integrity Testing.
Medical Device Packaging Dye Penetration Testing.
Medical Device Packaging Vacuum Leak Testing.
Medical Device Packaging Peel Testing.
Medical Device Packaging Burst Testing.
Medical Device Packaging Creep Testing.
Medical Device Shipping Validations and Shipping Testing
Simulated Use Te (
read more )..... | |
| 09-1512 |
Analytical Chemistry/Toxicological Laboratory required for lab testing to validate a cleaning process. Will supply three unique medical devices at four levels of cleanliness (dirty, min, nominal and max clean). Number of samples needed open to agreement. Tests needed as follows:
Cytotoxicity Test
Particle Count Test
Total Organic Carbon Analysis
Endotoxin Testing (
read more )..... | Closed |
| 09-0984 |
USA medical devices company needs FDA GMP clinical research laboratory for in vitro performance testing of aerosol delivery device that includes cascade impactor particle size testing. (
read more )..... | Closed |
| 09-0637 |
ISO and FDA GMP medical devices laboratory needed for ASTM, MRI compatibility testing for class III medical implantable device (Active) (
read more )..... | Closed |
| 09-0622 |
Medical Device Manufacturer requires US Laboratory for cytotoxicity testing on the medical devices we manufacture (
read more )..... | Closed |
| 09-0409 |
Large Medical Devices Manufacturer needs USA microbiology laboratory for microbial testing of treated antimicrobial surfaces. Must be able to work with S. aureus and have access to a confocal microscope. (
read more )..... | Closed |
| 08-2638 |
USA Medical Devices Biomaterials Laboratory needed for evaluating new plasticizers to be used in our primary bags. We have narrowed the selection to DINCH (1,2-Cyclohexanedicarboxylic acid diisononyl ester) or TOTM (Tri Octyl Trimellitate). I would like to be contacted to talk about your abilities to test for these compounds in a 4% sodium citrate solution.
(
read more )..... | Closed |
| 08-2635 |
USA FDA GMP Analytical Chemistry laboratory needed for USP light obscuration particle counting test per USP <788> for medical devices
(
read more )..... | Closed |
| 08-2603 |
Asia Analytical Chemistry, Materials Laboratory needed for recertification testing of Polycarbonate Resin, old grade which are over 2 years (the guarantee shelf life is 2 years). These resin are to be done injection and built parts which are assembled on to medical products. We would like to see whether they are still suitable for the Medical Devices application or not since they are now over 2 years.
(
read more )..... | Closed |
| 08-1506 |
Medical Devices Materials Laboratory needed for testing on HDPE and polypropylene for health certificate (
read more )..... | Closed |
| 08-1261 |
Medical devices Manufacturere needs ASTM physical strength testing of interference screws and anchors according ASTM STD . (
read more )..... | Closed |
| 08-0926 |
USA FDA GMP Microbiology Lab needed for cleaning/ disinfectant efficacy testing for reusable medical devices. Class II. Surface (skin) temperature sensor.
(
read more )..... | Closed |
| 08-0865 |
US FDA Florida microbiology lab needed for bioburden testing of medical devices used to insert sutures. (
read more )..... | Closed |
| 08-0632 |
ISO Asia microbiology and biomedical laboratory needed for all USP microbiological and physical testing on Medical Devices, Bone wax (
read more )..... | Closed |
| 08-0627 |
Large Medical Devices Manufacturer needs Bay, Area, California Non-CGMP Materials Lab needed for electron spin resonance of plastic extrusions. Looking to characterize free radical concentration at different times post irradiation. (
read more )..... | Closed |
| 08-0576 |
USA Packaging Lab needed to Provide temperature controlled environment, with humidity, for accelerated age testing of various sterilized and packaged medical devices. Lab to maintain large number of finished medical devices (potentially up to 8 pallets), sterile, flat, tyvek/poly pouches. Products are asyringes and similar devices)in controlled environment,with humidity, for accelerated age and real time aging testing to simulate up to 5 year shelf-life claims.
(
read more )..... | Closed |
| 08-0520 |
Large Medical Device Manufacturer needs Biomedical laboratory for ASTM D256 Testing of Medical Devices component (
read more )..... | Closed |
| 08-0366 |
Microbiology lab needed for microbial disinfectant efficacy study testing of microspheric beads used air-fluidized therapy (AFT) beds for patients with severe pressure ulcers (bed sores). The beads have to be disinfected after each patient use by heating them to 150 degrees over a 10-hour time span.
This method of sanitizing the beads is not very efficient and we have recently discovered that using ozone is a good method of disinfecting medical devices and wish to conduct hte disinfectant e (
read more )..... | Closed |
| 08-0365 |
Biophysical laboratory capable of performing aging studies and tensile tests on woven collagen dressings needed. We are performing aging tests on samples of the dressings medical devices, and we wish to determine how long term elevated storage temperatures effect the elasticity and tensile strength of the matrices over time. The samples are 1/8in x 2in x 3in. We are interested in contacting with you to perform 18 stress/strain measurements, providing a stress/strain curve for each sample and (
read more )..... | Closed |
| 08-0273 |
Medical Devices Manufacturer needs materials laboratory for MALDI analysis of synthetic polymer (
read more )..... | Closed |
| 08-0259 |
Analytical Chemistry laboratory needed for medical devices -
501k Submission testing:
Cytotoxicity
Sensitization
Irritation
Ames Mutagencity
Product Sterility for final package (3 year expiry)
Gamma Irradiation Testing - radiation dose, sterility validation method, sterility assurance level
(
read more )..... | Closed |
| 07-2510 |
Analytical Chemistry laboratory needed for sterility testing for EO Gas Sterilized Medical Devices (
read more )..... | Closed |
| 07-1927 |
Medical Devices Laboratory needed for FDA (1 CFR 1611) Flammability Testing of Plastic (
read more )..... | Closed |
| 07-1574 |
FDA GMP Microbiology laboratory needed for AAMI Testing of Cleaning and sterilization validation of medical devices reprocessed. (
read more )..... | Closed |
| 07-1146 |
ISO Medical Device Laboratory for cleaning efficacy validation and testing of reusable medical devices to AAMI TIR30, AAMI TIR12 (
read more )..... | Closed |
| 07-1019 |
FDA GMP materials laboratory needed for GPC testing Medical Devices polymer MW weight (
read more )..... | Closed |
| 07-0870 |
Microbiology laboratory needed for Cleaning efficacy validation and testing of reusable medical devices to AAMI TIR30. Manual and mechnical (washer-disinfector) cleaning validations on various reusable medical devices as per AAMI TIR30, ISO 15883 series, AAMI TIR12Cleaning efficacy testing of reusable medical devices AAMI TIR30 (
read more )..... | Closed |
| 07-0026 |
ISO Medical devices laboratory needed for testing injectibles and IUDs (
read more )..... | Closed |
| 07-0020 |
FDA Medical devices laboratory needed for testing infusion pump for regulatory submission and need verfication and validation testing to AAMI ID26:2004 and ISO60601-2-24. (
read more )..... | Closed |
| 06-1924 |
ISO, Non-GLP Medical Devices Materials Laboratory needed for ASTM Testing of a Polymer: melt flow (melt index), Molecular Weight (GPC), Rheology (Stress strain) (
read more )..... | Closed |
| 06-1722 |
Medical Devices manufacturer needs analytical chemistry laboratory for chemical testing process tank vapors. (
read more )..... | Closed |
| 06-1494 |
ISO Toxicology laboratory needed for Biocompatibility testing ISO 10993 -5 & 10.: Irritation, Cytotoxicity, Sensitasation, Irritation and Intracutenous reactivity test as per ISO 10993 -5 & 10 on Medical Devices. (
read more )..... | Closed |
| 06-1483 |
FDA GMP / GLP Medical devices laboratory needed for biocompatibility testing of medical devices (
read more )..... | Closed |
| 06-1414 |
GLP, ISO prouct safety laboratory needed for medical devices (biomaterial) biological safety testing including cytotoxicity
sensitization
irritation
genotoxicity
sub-chronic toxicity
implantation (
read more )..... | Closed |
| 06-1171 |
FDA GMP medical devices laboratory needed for testing rapid test kit (
read more )..... | Closed |
| 06-1100 |
ISO and FDA GMP medical devices laboratory needed for MRI compatibility testing for class III medical implantable device (non-active) (
read more )..... | Closed |
| 06-0691 |
Medical Devices company needs ISO medical device laboratory for ISO 7206-6, Fatigue testing for hip prosthesis. (
read more )..... | Closed |
| 06-0656 |
Medical Devices toxicology laboratory needed for ISO Cytotoxicity Testing (ISO 10993-5) for CE Marking and TUV Testing of upholstery materials (
read more )..... | Closed |
| 06-0655 |
GLP medical devices laboratory needed for processing fixed human coronary tissue from cassettes to H&E and Movat's pentachrome slides.
2) Using microscopy, classify pathology of coronary artery plaques according to a modified AHA scheme.
3) Using image analysis, perform morphometry measururements of plaques using custom software.
Approximately 75 slides for microscopy and imaging each per week for 6 months. One week turnaround time for each set of submitted tissue. (
read more )..... | Closed |
| 06-0653 |
Medical Devices manufacturer needs toxicology laboratory for ISO cytotoxicity testing (ISO 10993-5) for cytotoxicity of seat and back upholstery of wheelchair (
read more )..... | Closed |
| 06-0485 |
Toxicology laboratory needed for ANSI/AAMI/ISO 10993-6:1995, Biological Evaluation of Medical Devices-Part 6: Tests for Local Effects after Implantation. Tissue would arrive late April early May; Specimens from rats (
read more )..... | Closed |
| 06-0417 |
Medical Devices company needs analytical laboratory for determination of octanol water partition coefficient (
read more )..... | Closed |
| 06-0315 |
FDA, ISO, AAMI Accelerated Durability/fatigue testing of implantable medical devices (principally stents) including DES (
read more )..... | Closed |
| 06-0201 |
GLP medical devices laboratory needed for mechanical, ASTM / ISO Fatigue testing on an implantable medical devices
(
read more )..... | Closed |
| 05-0948 |
GMP and GLP Laboratory needed for validation of the cleaning and thermal disinfection of medical devices, by microbiology methods ISO/DIS 15883-1 (or PR EN 15883-1) Washer Disinfectors., specifically using automated washer-disinfector equipment. (
read more )..... | Closed |
| 05-0914 |
Toxicology Polymer analysis for the compliance to the Biological evaluation of medical devices ISO 10993-10 Tests for irritation ISO 10993-5 Tests for in vitro cytotoxicity (
read more )..... | Closed |
| 05-0690 |
particulates counts on guidewires medical devices (
read more )..... | Closed |
| 05-0683 |
CT and MRI compatibility 10-20 Medical Devices samples; required are images of a device (>2cm length) using a 1.5-5T MRI and CT scanner. (
read more )..... | Closed |
| 05-0574 |
Provide temperature controlled environment, with humidity, for accelerated age testing of various sterilized and packaged medical devices.
Lab to maintain large number of finished medical devices (approx. 6000 (approx. 8 pallets), sterile, flat, tyvek/poly pouches. Products are catheters and similar devices)in controlled environment,with humidity, for accelerated age testing to simulate up to 4 year shelf-life claims. (
read more )..... | Closed |
| 05-0466 |
Water extraction, ISO 10993-17 in medical devices disposable set-fluid path for sterile, one time use only set (
read more )..... | Closed |
| 05-0068 |
Testing of medical devices to GB/T14233.1-1998 & GB/T14233.2-1993 (
read more )..... | Closed |
| 04-0356 |
Pyrogen testing for medical devices (
read more )..... | Closed |
| 04-0260 |
Bioburden testing on approximately 6 batches of medical devices a week. Batches consist of sample size of 10. (
read more )..... | Closed |
| 04-0222 |
microbiological testing of water, OTC drugs, cosmetics and medical devices (
read more )..... | Closed |