Medical Device Testing

Why Medical device testing?

Medical device industry is driven by new technologies with continual innovation. Compliance with international standards for medical devices can be complex, and hence a trusted testing partner is the key. Our scientists have extensive backgrounds in handling and testing of single use and reusable medical devices.

Prewel Labs is NABL accredited for ISO 17025:2017 and follows Good laboratory Practices (GLP). We work with your company by adhering to the Quality Management System (QMS) and fulfil your unique needs in medical device testing.

Prewel Labs offers a variety of tests for medical devices.  Most studies are tailored to particular devices.  The lab is an excellent choice for companies that wish to evaluate the performance of antimicrobial devices such as catheters, ports, and wound dressings.  The methods listed below are just a sampling of our capabilities:

Types of Medical Device Testing

  • 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
  • Medical Device Process Validation
  • Sterility Method Validations
  • Cleanroom Microbiological Environmental Monitoring and Qualifications Programs
  • Bioburden Method Validations
  • Biological Indicators Evaluation and Enumeration

Why Partner with Prewel Labs?

With 30 plus years of combined experience in Pharmaceutical industry nobody understands the Pharma regulations as we do. Not just that, our well trained scientists ensure we meet your project needs and exceed your expectations. Here are some of the benefits of partnering with us:

NABL Accredited

Know how of Medical device industry

Adherence to National & International Regulations

Strong technical team

Customized project design

On time delivery