IVDEXEL

IVDEXEL is the MedTech service provider with expertise in Regulatory, Quality and Audits. With more than 15 years of experience in product development, QA and RA, we also provide independent audit service for meeting your ISO 13485 requirements. Our support will help your company to register your products, reducing risk throughout the product lifecycle for medical devices and IVDs.Special support for Medical Devices and IVDs:• Implementation of your QMS, gap analysis, medical writing.• Audits preparation: ISO 13485, ISO 9001, MDR, IVDR, MDSAP. Internal audits programs, independent audits.• Support with standards: Risk Management System, Software for Medical Devices, stability of reagents, etc.• Systematic Post-market activities. (PMS, PMPF, PMCF, PSUR)• Performance Evaluation: from PEP to PER. (APR, CPR)• Literature Search Report and State of the art. • Product registration.No matter if you are a start-up or an established medical device company, IVDEXEL can support your daily activities for Regulatory and Quality Assurance.