Sanatmetal Ltd. fared excellently between 11 and 13 September 2018 on a quality management audit of strategic importance. Our company was among the first medical device manufacturers to change over from the EN ISO 13485: 2012 system to the new quality management system requirements for medical manufacturers and obtained the EN ISO13485: 2016 certification by the BSI Certification Body. The value of this achievement is increased by the fact, that the audit did not reveal any non-compliances to the new standard, and even several company strengths were highlighted in the audit report.
Medical device manufacturers are now facing new and significant challenges in the field of regulations, something the company began to prepare for with the introduction of the above mentioned standard. The Medical Device Regulation, serving patient’s safety, will come into effect soon, and the Uniform Device Identification (UDI) system, and the EUDAMED database (allows for public access to data) will bring significant tightening for manufacturers. As a result, probably a tough „natural selection” phase is about to begin and only those players will survive on the market, who have the knowledge, resources and determination to fully meet the new requirements.