Positive ISO13485 Surveillance Audit

Positive ISO13485 Surveillance Audit
Baris Dogan
Baris Dogan
Head of Design
SCARLETRED is announcing the positive outcome of our first surveillance audit of our ISO1345 certified quality management system. The audit  was conducted at 16. April 2020 by the notified body SIQ via fully digital procedures. 
 
SIQ as a certified body regularly checks the conformity of the holders management systems with requirement of the chosen standard at least once a year; in case of SCARLETRED Holding GmbH the medical device standard ISO13485 applies, an international harmonized standard defining the requirements for a quality management system, wherein an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. 
 
Very special and hopefully a unique experience for both parties, was the situation that the audit had to take place in a phase of very strict travel and health safety regulations, meaning both teams had to prepare and work from multiple remote locations. Therefore we decided to makes use SCARLETED’s well established and for 100% online based digital procedures, which assured also that our services stayed fully operational in the current COVID-19 crisis. 
 
We are very happy to say that the audit went very well and no minor/major findings have been detected in our system. Hence our ISO13485 certificate stays valid which is of course a very good news for us but even more it is a great news for our clients and partners who need our high quality and trustful digital products and services. In addition to this and needles to say our system complies with European General Data Protection Regulation (GDR), the US Health Insurance Portability and Accountability Act (HIPAA) and the Act on Protection of Personal Information (APP) in Japan. It  enables to introduce an ICH-GCP conform digital process flow and due to recent advances enables now also location independent real time Telemedicine services. 
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