Bioexcel https://validator.w3.org/feed/docs/rss2.html Q3. Do the platforms generate regulatory reports automatically? Q2. Can the platforms be used independently of Bioexcel services? Q1. Are Vigi X™ and Xceltrials™ regulatory‑approved software? CDSCO Update on IVF and ART Medical Devices Blog Q- Is ISO 10993 required for all medical devices? Q-Do you perform biocompatibility testing? Q- What is a Toxicological Risk Assessment (TRA) in medical devices? Q-Can toxicology outputs be used in EU MDR technical documentation? Can the same clinical evidence be used across regions? Does Bioexcel guarantee regulatory approval? vigix360 Global Regulatory Strategy & Lifecycle Support PMCF & PMS Services – Medical Devices Performance Evaluation Report (PER) Services – IVDs Clinical Evaluation Report (CER) Services – Medical Devices Clinical & CRO Services UKCA & MHRA Support US FDA Regulatory Submissions Technical & Quality Nitrosamine Risk Assessment & Control Extractables & Leachables Risk Assessment PDE, OEL & CLP Compliance Cleaning Validation & Cross-Contamination Control Toxicology Testimonial 3 Testimonial 2 Testimonial 1 Medical Devices Digital Compliance Platform Regulatory Affairs Services Real‑World Evidence (RWE) Clinical Investigation Services for Medical Devices About TestPage Q4. Can RWE be used in CER or PER updates? Q3. What data sources are acceptable for RWE? Q2. Can RWE replace a clinical investigation? Q1. Is RWE mandatory under EU MDR or IVDR? CDSCO & India Regulatory Support What Notified Bodies Expect in a CER Under EU MDR VigiX 360 Xceltrials™ Clinical Evidence & CTMS Platform Vigi X™ Materiovigilance & PMS Platform EU MDR & IVDR Regulatory Strategy Contact Home Medical Device Usability Enquiry Bioexcel Case Study