We would like to be the solution partner of Medical Device manufacturers, by providing guidance in QUALITY, REGULATORY & CLINICAL affairs, organizing technical trainings, and proven advices for MDR & IVDR compliance. Our goal as a consultancy company is to be a one-stop-shop to provide a wide range of services to medical & IV diagnostic device manufacturers regarding ISO 13485 Quality Management Systems, MDR & IVDR documents such as STED, Usability, PMS, PSUR, CER, PMCF, SSCP and also Clinical trials. If you need a trusted , reliable and affordable consultancy, you are on the right page. With our expert teams who have deep know-how in quality and regulatory, you are going to save time and increase your operational efficiency. Please do check our references from our web site.
