35% of all medical device reports filed with the FDA go through Smarteeva. That share comes from one early decision. Post-market quality is the product we build, so every release goes into complaints, adverse events, PSURs and recalls. In Smarteeva, the complaint, the reportability decision and the eMDR sit in one record. Filing through ESG NextGen takes under 3 minutes. If your MDRs still start with copy and paste, the demo link is in the first comment. #PostMarketSurveillance #MedTech #MedicalDevices

Most eQMS platforms started with document control and training. Complaints arrived later, as a module. That holds up until post-market volume grows. Then complaints get exported to a spreadsheet for the PSUR, MDR fields get re-keyed, and recall acknowledgements get tracked by email. This carousel sets what a typical post-market module covers next to what the work asks for. Swipe through and tell us in the comments where your current setup stops. Tell us in the comments 👇 #QualityManagement #MedTech #MedicalDevices

How long does it take to replace a post-market system? At Smarteeva, the standard implementation runs 12 weeks in four phases. ☑️ Weeks 1 to 3: we map your current complaint workflows, data structures and integration points. ☑️ Weeks 4 to 8: we configure the platform and migrate historical data with full integrity validation. ☑️ Weeks 9 to 10: Smarteeva runs alongside your current system, so your team can check accuracy before cutover. ☑️ Weeks 11 to 12: go-live and legacy decommission, with a dedicated support team for the first 30 days. Regulatory operations keep running the whole way through. #MedicalDevices #PostMarketSurveillance #QualityManagement

Open most free ISO 14971 templates and you'll find a detection column. ISO 14971 doesn't use one. The standard estimates risk from the severity of harm and the probability that harm occurs. Detection comes from automotive FMEA, and a high detection score can pull a risk rating down in a way an auditor may question. We built a free template that follows the standard's own chain: Hazard → sequence of events → hazardous situation → harm Inside the workbook: ▶️ Five tabs, from document control to overall residual risk ▶️ Editable severity and probability scales with an acceptability matrix ▶️ Columns for verification, risk reduction as far as possible, and links back to complaint data ▶️ Five worked examples for a fictional infusion pump Download link in the first comment. Does your current risk template have a detection column? #ISO14971 #RiskManagement #MedicalDevices #RegulatoryAffairs

Most ISO 14971 risk files start the same way: a blank spreadsheet and a lot of copying from the last project. We put together a free ISO 14971 risk management template so your team can skip that step. It gives you a structured place to document hazards, estimate risk, and record the controls you put in place. Download it, adapt it to your device, and put the hours into the analysis itself. Get the free template; link in the comments 👇 #ISO14971 #RiskManagement #MedicalDevices #MedTech #RegulatoryAffairs