We offer microbiology consulting and testing support for medical device manufacturers who require sterile products. From bioburden determination to sterility testing and environmental monitoring, we ensure your processes are microbiologically sound and inspection-ready — in line with ISO 11737 and ISO 14698.

We don’t just deliver results — we help you understand them, act on them, and defend them during audits.

Our Microbiology Services Include:

• Bioburden test setup and routine monitoring

• Sterility testing protocol design and troubleshooting

• Environmental monitoring strategy and trending

• Support for microbial excursion investigations

• Documentation aligned with ISO 11737-1/-2

• Advisory on microbiological control in cleanrooms

• Annual microbiological performance review.
  
  Our approach combines lab insight with regulatory intelligence, helping you stay compliant and confident.