ISO 13485 certification: What is it?
Safety and quality are essential to the medical device industry, which is why establishing an ISO 13485 certified QMS is key to ensure these devices are developed correctly. ISO is the International Standardization Organization which defines the requirements for quality management systems specific to various critical industries. The ISO 13485 medical device certification regulations have become the standard of Quality System regulation for the FDA and its international equivalents, focusing on a risk-based approach to product development.
While many product development companies operate to ISO 13485 certification standards for medical devices and software, not all possess their own ISO 13485 Certified QMS. Obtaining ISO 13485 medical device certification for the Quality Management System requires rigorous internal audits by an independent third party. Their inquiry examines a company’s entire body of operating procedures, ensuring everything from the calibration of instruments to the naming of documents, is airtight. Successful completion of audits show that a company’s practices are completely oriented to ensure their designs meet FDA standards of documentation.
Quality Assurance in Nectar’s Process
The products Nectar develops must be trusted to improve, and sometimes even save, patient’s lives. Thus the creation of products must be finely tuned, requiring tedious and detailed assessment; an ISO 13485 certified QMS is proven to support this undertaking.
For Nectar, being ISO 13485 certified goes beyond holding this highly qualified certificate. Our medical device quality assurance has been woven into our DNA as regulatory compliance standards can be found through each step of our proven process. From research to verification, Nectar’s quality engineers track and record every single variable to ensure our medical devices and products are safe and reliable.
For our clients and consumers, our ISO 13485 medical device certification and quality assurance system can assure that your medical devices and software systems are achieving the most prestigious standards possible in the global market.