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Medical Device Testing Services

Medical Device Testing Services

We share a proud history with those in the medical device industry as we have tested many of the innovative medical products on the market today to ensure they perform safely and effectively. With the enactment of the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, the U.S. government began their oversight of medical devices. Subsequently, U.S. Congress chartered the Cooper Committee to take inventory of all medical devices currently in use. Following that review, the 1976 Medical Device Amendments were passed giving authority to the U.S. FDA to regulate medical devices. This dramatically altered the medical device industry and ultimately gave rise to Nelson Laboratories.

We are over 700 scientists, technicians, and service specialists diligently performing more than 400 rigorous tests in 11 global laboratory locations. With decades of foremost expertise, we stand behind the quality of our results and the strength of our customer partnerships. 

Biocompatibility & Toxicology

We offer a full range of materical assessments using chemical characterization, in vivo and in vitro test services to meet US FDA, EU CE mark Japan MHLW and other international requriements.

  • Chemical Characterization - ISO 10993-12, ISO 10993-18
  • Cytotoxicity - ISO 10993-5, USP <87>
  • Genotoxicity - ISO 10993-3
  • Hemocompatibility - ISO 10993-4, ASTM F756-13
  • In Vivo - ISO 10993

Sterilization Validation

Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed. 
  • Ethylene Oxide (EO) Sterilization - ISO 11135
  • Radiation - ISO 11137, ISO 13004:2013
  • Resuable Devices, Kits and Trays - ISO 17665, AAMI ST79

Cleaning Validation

Cleaning validations are custom to contact type, device type, and size.
  • Reusable Devices
  • Newly Manufactured Devices and Implants

Packaging Validation and Testing

Packaging validation is a way to test the sterile barrier system (SBS) and demonstrate that it can be maintained over time. 
  • Packaging Validations - ISO 11607
  • Accelerated Aging - ISO 11607
  • Real-Time Aging - ISO 11607
  • Mass Extraction - TBD
  • Distribution Studies - ASTM D4169, ISTA 3A
  • Microbial Barrier Tests - ISO 11607

Product Validation and Lot Release Testing

Routine monitoring of the manufacturing processes. 
  • Bioburden - ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
  • Product Sterility - USP 71, USP 161, USP 797 EP 2.6.1, JP14 54, ANSI/AAMI/ISO 11737-2 - 2006, AAMI TIR 33
  • Bacterial Endotoxin Test - USP 85, USP 161, USP 797, AAMI ST72:2002, EP 2.6.14
  • Particulate Analysis - USP 788

Microbial Identification & Analysis

There are several options available for organism identification, and choosing the right system depends on the type of information you need - and the type of organism. 
  • Organism Identifications - USP 71, ISO 11737
  • Harmonized Microbial Enumeration - USP <61>
  • Harmonized Absence of Specified Organisms - USP <62>

Environmental and Water System Monitoring

Environmental monitoring includes auditing the key components of a controlled environment including water, air, surfaces, equipment, and personnel. 

  • Environmental Water Samples - Standard Plate Count by Membrane Filtration
  • USP/EP Water Tests
  • Environmental Monitoring - Incubation and Enumeration
  • Disinfectant Studies
  • Antimicrobial Studies

Barrier Material Performance Tests

We offer a wide range of tests for bacterial and viral filtration efficiency and other barrier qualities for wovens,   nonwovens, and barrier material manufacturers (masks, gowns, gloves). 
  • General Use, Medical Masks, Surgical Masks, Flat Stock Filter Media & Housed Filters
  • Microbial Cleanliness for Face Masks - EN 14683
  • Tests for Face Masks with Alternate Organisms - VFE200
  • Mask Certification Program
  • Alternate Filter & Mask Filtration Efficiency Tests
  • Tests for Filter Systems and Housed Filters
  • NIOSH 95 and Respirator Pre-Certification Tests - 42 CFR Part 84
  • Surgical Drapes and Gowns - AAMI PB70, ISO 16603, ISO 16604
  • Drapes & Gowns - EN13795
  • Glove Tests
  • Tear Release - ASTM D5587
  • Tensile Tests - ASTM D882, EN 29073-3
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