“The certification to ISO 13485:2016 allows Meddux to offer its customers a streamlined path from concept to first-in-human clinical trials,” said David Schechter, president of Meddux. “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 can efficiently produce sterile packaged clinical lots within a certified Class 8 controlled environment. For most early stage start-up companies, achieving first-in-human clinicals is the single most important milestone for attracting additional institutional investors. Customers can now leverage Meddux’s systems and experience to 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, vice president of Quality and Operations. “The 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.”
Meddux’s QMS was built from the ground up with a focus on designing a system that could be both flexible and compliant. Achieving the certification was a real team effort and is a testament to the culture of quality at Meddux.