Meddux Development announced that it has received ISO 13485:2016 certification for its quality management system.
“The certification to ISO 13485:2016 allows Meddux to offer its customers a streamlined path from concept to first-in-human clinical trials, David Schechter, president of Meddux, said. “Meddux has developed a flexible and responsive QMS capable of handling the most critical aspects of medical device product development, including risk management, design controls, design history files and device history records.”
Meddux currently develops sterile packaged clinical lots in a certified Class 8 controlled environment. It customers can use the company’s systems and experience to help achieve a streamlined path to first-in-human trials.
“This is a major milestone for Meddux in a process we started well over a year ago,” said Chad Herremans, VP of quality and operations at the company. “This ISO 13485:2016 certification is an expectation of our customers and in many ways a requirement to do business in our industry. We are pleased to now offer our services under the certification.”