This Customer Feedback & PMS PSUR SSCP PMCF Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines processes for collecting customer feedback and conducting post‑market surveillance, periodic safety update reports, summary of safety and clinical performance, and post‑market clinical follow‑up. Digital delivery within 24 business hours.
This procedure ensures systematic collection and evaluation of customer feedback and post‑market data to maintain compliance and product safety. It covers PMS activities, PSUR preparation, SSCP documentation, and PMCF studies. Delivered in editable Word format for customization. Consultancy services are available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are offered at an extra fee.