Go to Client Portal
NAMSA
Medical Device Testing

Controlled Environmental Regulatory Testing Services

TRUST US TO PROVIDE ULTIMATE COMPLIANCE AND QUALITY ASSURANCE FOR YOUR MEDICAL DEVICES.

Contact Us

We provide controlled environmental regulatory testing services to meet the requirements of quality system regulations when such an environment can influence the pre-sterilization bioburden testing level or resistance on a medical device.

Our medical device testing experts ensure that clients conduct the appropriate amount of sampling to suit their particular environmental monitoring needs and requirements. We not only provide you with a protocol and track your data, but also document results that will support your full sterility assurance program.

Our capabilities relating to environmental testing include the following:

  • Acute Systemic Toxicity Testing
  • Biodegradation Testing
  • Carcinogenicity Testing
  • Chronic Toxicity Testing
  • Cytotoxicity Testing
  • Genotoxicity Testing
  • Hemocompatibility Testing
  • Implantation Testing
  • Intracutaneous Irritation Testing
  • Reproductive/Developmental Testing
  • Sensitization Testing
  • Subchronic Toxicity Testing

Resources

Literature
Biocompatibility Matrix
Learn More
White Paper
Reducing Medical Device Development Timelines & Creating Value through Biological Risk Assessments & Chemical Characterization
Learn More
White Paper
Particulates in Preclinical Testing: Understanding the Impact on Overall Device Biological Safety
Learn More
White Paper
Medical Device Biological Evaluation Reports: Relevance to ISO 10993-Part 1: 2018
Learn More
Webinar
The New ISO 10993-18:2020 – 10 Things Manufacturers Need to Know Today
Learn More