PDO Max Inc, a provider of U.S. FDA-cleared polydioxanone (PDO) threads-in-cannula medical devices for non-surgical facial tissue repositioning, announces that its PDO device continues to comply with the Medical Device Single Audit Program, or MDSAP, certification.
Being MDSAP certified means that your company has met the quality management standards of multiple, regulatory jurisdictions including those of Australia, Brazil, Canada, Japan, and the United States. Accoridng to the FDA’s website, “a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.”
PDO Max is also ISO-13485: 2016 certified, which means they have demonstrated their ability to provide medical devices under very rigorous quality expectations. ISO-13485: 2016 evaluates whether a company’s Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.
PDO Max is focused on quality management, safety, and training of its absorbable PDO threads-in-cannula. Just as they took the time to go through the rigorous FDA approval process (K190245), they took the time to participate in a global auditing certification to ensure they meet the highest safety and high-quality device standards on a global scale, according to company officials.
“At PDO Max, we don’t cut corners, and we take the time to make sure we are doing everything the right and safe way so that medical practitioners can sleep at night knowing that our FDA cleared medical device that was placed in their patient’s skin is safe, reliable, and effective,” says Giovanna McCarthy, CEO and founder of PDO Max.
Among their safety certifications, the company and manufacturer are fully insured. The PDO threads are designed and manufactured by PDO Max, and every package is properly labeled with our branding, lot numbers, and QR code so that the company and the clinic can track the device being used in the event of a complication.