Para-Coat Technologies Expands Certification— 21 / 09 / 2020
Para-Coat Technologies, Inc. (PCT-Johnstown, Pa) recently received ISO 13485 certification for its quality management system from Eagle Registration. “We are very proud of this certification, it demonstrates the commitment of our team to quality and to meeting our customers regulatory expectations”, states Krista Rager, CEO of PCT.
The new ISO certification ensures that the company’s quality management system meets current regulatory requirements that are specific to the medical device industry. “The implementation of ISO 13485:2016 is the best internationally recognized model to help demonstrate that PCT has successfully complied to the laws and regulations of the medical devices industry,” said Dave Pribish, General Manager, for Para-Coat Technologies. “This certification represents an important milestone for our company and reflects the focus we have on risk-based decision making throughout our organization with a commitment to safety and providing a high-quality product.”
The ISO 13485 certification, in addition to our current ISO 9001:2015, verifies that Para-Coat Technologies, Inc. operates in a way that is consistent with international medical device development and quality management systems specifications as established by the International Organization for Standardization. Obtaining ISO 13485 also serves to validate PCT’s commitment to delivering the highest level of quality and consistency in its products and services to its clients, which is in line with the company’s mission and values.