At the end of April, an auditor from the accredited certification body for QM systems mdc medical device certification GmbH once again put the processes and guidelines in our company through their paces for three days as part of an initial certification in accordance with DIN EN ISO 13485. This year, after already successfully being recertified in 2021, we decided to have ourselves audited by a certification body accredited by the German Accreditation Body (DAkkS) in the future. Last week, the audit committee issued us the certificate for another 3 years. This means that we have stood for certified quality for more than 10 years.
What is the point of subjecting ourselves to an audit again and again? In short, it is not enough for us to believe that we are good at our daily business. We also want to know and be able to prove it - and that's why we have ourselves regularly audited by an independent body.
With certification according to DIN EN ISO 13485, we ensure that the quality of our products and services meets the highest standards. With the certification according to DIN EN ISO 13485, we also ensure the information security - i.e. in particular the availability, confidentiality and integrity - of our services. Among other things, this is also achieved by ensuring that only materials are used in production that meet the basic safety and performance requirements in accordance with Annex I of the Medical Devices Regulation (EU) 2017/745 (MDR) and for which a conformity assessment procedure has been successfully carried out by the manufacturer in accordance with the requirements of the respective directive for this product group.
But after the audit is before the audit: Instead of sitting back, we will continue to invest in quality and information security to continuously increase the maturity of our system for you, our customers.
Your Team INFINIDENT