IVDEXEL

IVDEXEL is a MedTech service provider specializing in regulatory, quality, and auditing services. With over 15 years of experience in product development, quality assurance, and regulatory affairs, we offer independent audit services to help companies meet ISO 13485 requirements. Our support assists companies in registering their products, mitigating risks throughout the product lifecycle for medical devices and in vitro diagnostics (IVDs). We provide specialized support for medical devices and IVDs, including: - Implementation of quality management systems (QMS), gap analysis, and medical writing. - Preparation for audits such as ISO 13485, ISO 9001, ISO 17025, ISO 15189, Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and Medical Device Single Audit Program (MDSAP). We also offer internal audit programs and independent audits. - Support with standards such as risk management systems, software for medical devices, and stability of reagents. - Systematic post-market activities, including post-market surveillance (PMS), post-market performance follow-up (PMPF), post-market clinical follow-up (PMCF), and periodic safety update reports (PSUR). - Performance evaluation, from performance evaluation plan (PEP) to performance evaluation report (PER), including annual performance reports (APR) and clinical performance reports (CPR). - Literature search reports and state-of-the-art reviews. - Product registration services. Whether you are a startup or an established medical device company, IVDEXEL can provide comprehensive support for your regulatory and quality assurance needs, ensuring compliance and reducing risks throughout the product lifecycle.