Contract Laboratory has received the following Medical Devices Laboratory Test Requests which need to be fulfilled! These Laboratory Test Requests are received from a variety of sources ranging from start-up companies to large, multinational Fortune 500 corporations, international organizations, well-respected universities and government agencies that are actively seeking Independent, Third-Party Medical Devices Laboratories to perform their Medical Devices Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Medical Devices laboratory that would like more information on these Medical Devices projects, please visit our registration page or call toll us free 1-855-377-6821.
FDA Medical Device Laboratory needed for ISO VOC, particulate, CO and CO2 testing for ventilator components with dry gas pathway contact for emergency and transport ventilator to ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
FDA GLP Medical Device Laboratory needed for performance testing of medical resuscitator to ISO 10651-4 Manual Resuscitator. The test to be performed include:
Delivered O2 concentration
- Expiratory resistance
- Inspiratory resistance
- Patient valve
- (Dead space
- Tidal Volume
Clinical laboratory needed to perform clinical study of product that lowers your blood alcohol content with 150 people with 100 being given the product and 50 a placebo. The test subjects will have to drink three 1.5 ounces of vodka in an hour. Their blood alcohol will need to be tested with 20 individual DOT certified breathalyzers every half hour. The study will need to last 3 hours from beginning to end.
Medical device laboratory needed for cleaning validation study of the water cleaning cycle of a plastic covered electronic tracking device . Simulation of the a 150C temperature water cleaning cycle for 30 minutes over a 500 cycles tis needed to ensure that this product can withstand the temperature, time and cycles. I would provide a fixture with 10 units for this test
Medical Device laboratory needed for ISO pre-compliance filter testing on medical ventilation module in accordance with ISO 23328-1:2008 standard, Breathing system filters for anaesthetic and respiratory use -- Part 1: Salt test method to assess filtration performance
The standard specifies a salt (NaCl) filtration challenge.
Medical electrical laboratory needed for IEC testing of sterile electrosurgical products to IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
FDA GMP medical device laboratory needed for testing to support FDA 510(k) based on FDA-recognized consensus standards: 3-80 AAMI ANSI ISO 81060-1:2007/(R)2013 - Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type and 3-96 ISO 81060-1 First Edition 2007-12-01 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
Medical device laboratory needed for ISO testing of blue light and UV ray blocking optical lenses including ISO 8980-3, Ophthalmic Optics - Uncut Finished Spectacle Lenses - Part 3 Transmittance Specification and Test Methods.
ISO 14889, Ophthalmic Optics - Spectacle Lenses - Fundamental Requirements for Uncut Finished Lenses.
ISO 17025 medical device laboratory needed for full VDmax25 sterilization validation on titanium orthopedic screws to ISO 11137 including bioburden validation (correction factor), bioburden determination on three lots of product, delivering the verification dose, sterility testing, microbiological identification and BF testing. We are also seeking BF testing on a titanium intramedullary nail.
Medical Device laboratory needed for passive ligating clip medical implant testing to several ISO and IEC standards including:
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
IEC 60601-2-33 Medical Electrical Equipment Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis,
ISO 14971 Medical Devices Application of Risk Management to Medical Devices,
ISO/IEC Guide 51 Safety Aspects Guidelines for their Inclusion in Standards,
ISO TS 10974 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable
Medical device laboratory needed for physical ASTM testing of a range of titanium surgical-grade products to the following ASTM Standards: ASTM F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging, and ASTM F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO and FDA cGMP Medical Device Laboratory needed for validation study of the cleaning, disinfection (manual and automated), and sterilization of medical devices including bioburden, sterility, endotoxins, validation of sterilization procedures, and validation the cleaning and disinfection process to comply with requirements of CE (EC) and also those of the FDA. We are aware that some tests / tests differ.
Medical Device Laboratory needed for microbiology and physical testing of medical drapes and surgical gowns to several EN ISO standards:
1. EN ISO 22612 Resistance to Microbial Penetration - Dry,
2. EN ISO 22610 Resistance to Microbial Penetration - Wet,
3. EN ISO 11737-1 Cleanliness - Microbial,
4. EN ISO 9073-10 Cleanliness - Particulate Matter/Linting,
5. EN 20811 Resistance to Liquid Penetration
6. EN ISO 13938-1 Bursting Strength - Dry,
7. EN ISO 13938-1 Bursting Strength - Wet,
8. EN 29073-3 Tensile Strength - Dry and,
9. EN 29073-3 Tensile Strength - Wet
Medical Device laboratory needed for physiochemical testing including thermal, mechanical and dynamic analysis to support the development of a new transdermal patch. Studies to include rheology measurements on native adhesive and the drug-in-adhesive formulation to assess changes in the visco-elastic properties of adhesive, elastic or storage modulus, viscous or loss modulus, ratio of viscous to elastic modulus, and intrinsic or complex viscosity.
Large company needs medical device laboratory needed for ASTM testing of 4 orthopedic products including metallic medical bone screws, metallic angled orthopedic fracture fixation device, external skeletal fixation device, and metallic bone plates to ASTM F543 Annex A1, A2, A3 / ASTM F384 Annex A1, A2 / ASTM F382 Annex A1, A2 / ASTM F1541 Annex A5 and ISO 10334 or ISO 5838-1.
Biomechanical / medical device laboratory needed for development of spinal implantable device manufactured with implantable grade PEEK and Titanium 3. The following testing is required:
1. Slippage test - the implant spikes or serration should be strong enough so that it should not slip from the two bones,
2. Load bearing test - the implant should be able to take the load of up to 5kg,
3. Compression test - the implant should not slip or crushed while its compressed by surgical instrument, and
4. Biocompatibility test - the implant should not react to human tissues while inside the human body permanently.
Oncology Preclinical Contract Research Organizations CRO needed for in vivo studies of primary or metastatic hepatic / liver cancer using VX2 rabbit and/or Walker 256 rat/mouse orthotopic models. CRO must allow drug payload to be delivered by an external magnetic set up, steered by an MD/bioengineering member of our team.
Bioanalytical laboratory needed for analytical chemistry and microbiology testing to support stability extension of hydrolyzed collagen used in medical devices including viscosity, clarity, color, ash, moisture, pH, SO2, chromium, lead, heavy metals, PCP, fluoride, protein, bulk density, total bacterial count, salmonella, e coli.