HAI Solutions Receives ISO 13485 Certification
Santa Barbara, California | Newswire.com
HAI Solutions, a medical device company focused on innovative vascular access solutions, announced today it received its ISO 13485:2016 certification from Intertek. This international standard provides manufacturers, designers, and suppliers to the medical device industry with a framework necessary to demonstrate compliance to regulatory requirements and mitigate risks to stakeholders.
The certificate states that HAI Solutions quality management system conforms to the requirements of ISO 13485. It is applicable to: The design and development, and manufacture of vascular access and disinfection/sterilization devices.
"It tells a story that HAI Solutions has a solid quality system that meets, not just the FDA requirements, but also many other countries. This will translate into seamless regulatory approvals, high customer satisfaction, and most importantly a well-validated product that is highly reliable", said Adnan Abbas COO of HAI Solutions.
The ISO 13485 certification signifies the business meets all Quality System Requirements (QSR) defined by the FDA. In turn the FDA recognizes the ISO 13485 certification and consequentially identifies the business as being a system that requires less audits. Adnan stated that, "Many countries recognize the ISO certification and in doing so, it paves the way for any international medical device approval submission(s)."
HAI Solutions worked with global accrediting body Intertek to ensure their quality management system fulfills the regulations set forth by the medical device industry. The rigorous, multi-stage audit was conducted over the past few months. "Meeting this milestone is a great achievement and further validation of our company's commitment to quality and safety in the pursuit to develop superior products to protect every patient", said Nicholas Perrenoud, CEO of HAI Solutions.
About HAI Solutions
Based in Santa Barbara, CA, HAI Solutions is developing a novel and diverse platform of innovative intravenous therapy solutions targeting IV contamination for the Operating Room, Intensive Care Unit and Emergency Room. We believe in protecting every patient by building innovative medical devices which address the challenges and pitfalls associated with Intravenous Care and Vascular Access. We are advancing clinical care across the healthcare spectrum.
For More Information Contact (Media): Admin@HAI-Solutions.com
