Medical device companies need strong technical support in their quest to bring safe and effective products to patients and their doctors. PBL provides a broad array of services to support device development and manufacturing—from materials selection and device design through manufacturing and lot release.

Biocompatibility testing procedures help device engineers screen materials for safety characteristics. Finished product testing per ISO 10993 provides documentation of device safety for regulatory approvals. Surgical services may be needed to evaluate device safety and efficacy or to train physicians in the use of new surgical technologies.

Sterilization validation is required to assure the efficacy of sterilization cycles, whether gamma, e-beam, ethylene oxide or steam. Where dosimetric or parametric release is not practical, lot release sterility testing may be necessary to demonstrate that safety requirements have been met.

The pages in this section of the PBL web site contain a wealth of technical information about device biocompatibility testing, surgical services, and sterilization microbiology. Should you have additional questions on any topic, please feel free to contact BizDev@PacificBioLabs.com. They will direct your inquiry to the appropriate technical expert.

"I am very happy with the wonderful support you have provided. You are always responsive and patient. I have to say, 'A job well done on customer satisfaction!' "

- Manufacturing Engineer
   Minneapolis, NM

Medical device testing at PBL is performed according to current FDA and international guidelines and regulations, including ISO 10993 and various AAMI sterilization guidelines and TIRs. PBL is fully compliant with GLP and device GMP regulations.

With a 25-year track record of providing regulatory science services to medical device companies, PBL is an acknowledged leader in the industry. PBL reports have supported hundreds of 510k, IDE and international submissions. Our staff has experience with a huge variety of device materials and configurations.