Successful Outcomes One Client at a Time

Recently, BioTeknica assisted a leading medical device manufacturer to successfully address a previous FDA Warning Letter by helping them to improve their quality systems, remediate records, and organize, prepare and support the FDA re-inspection process.

“We were able to make significant improvements over the past year and half, with assistance from BioTeknica, and our design and manufacturing systems are now much better suited to benefit the patients who use our products,” said the vice president of Quality Assurance. “Because they work with a variety of life science manufacturers, BioTeknica was able to quickly assess and assist us by applying the latest methods for remediation and inspection readiness. Our patients and our business will continue to reap the rewards of our hard work in the future.”

Interpreting the ever-evolving regulations as they apply to each manufacturer’s unique situation is no easy task. The regulations apply to every aspect of the product life cycle, from product design to manufacturing, including the selection of raw materials, installation of equipment and facilities, product testing, validation protocols, packaging, shipping, staff training and process documentation.

“We’re often onsite at a client’s facility for weeks or months at a time, and it’s because we design solutions that are ultimately simple, systematic and sustainable for the client,” said Mike Neaves, Principal at BioTeknica. “Our goal is not only to assist clients in maintaining compliance while remaining sensitive to their bottom line, but ultimately, to help them consistently produce safe products that benefit people.”