Quality Assurance

BioMed’s quality system is certified to ISO 13485 and FDA cGMP. We are also EU compliant. This system is the foundation we use to insure product quality and on-time shipments.

  • Stability – extensive expertise in conducting stability studies
    (accelerated and real time)
  • Freeze – Thaw studies
  • Shipping tests
  • Preservative Effectiveness Testing
  • Biocompatibility, Cytotoxicity and Skin Irritation tests
  • Pathogen and Bacterial endotoxin testing
  • Environmental monitoring
  • Antimicrobial Effectiveness Testing (AET)
  • Formulation and Packaging Compatibility

BioMed is FDA registered for medical devices and drugs.

We adhere to our customers’ specific quality requirements.

Our team includes experienced chemists, microbiologists, lab technicians, QC inspectors, project engineers, validation technicians and regulatory compliance specialists. Working within a cGMP environment, they ensure FDA guidelines are met. The team clarifies requirements, and ensure that products are manufactured that exceed your expectations.