Post-Market Surveillance (PMS) report writing is essential to monitor device performance, ensure ongoing safety, and maintain regulatory compliance across global markets.
Syrma Johari MedTech supports this through end-to-end PMS report development, including data aggregation, trend analysis, signal detection, and preparation of PSUR/PMSR in line with EU MDR and global requirements. Delivered by experienced regulatory and medical writing teams, SJML helps OEMs ensure continuous compliance, strengthen product performance insights, and sustain market access.
Device-family PMS strategies and plans aligned to EU MDR, FDA, and global regulatory requirements for consistent post-market compliance.
Systematic collection and evaluation of complaints, vigilance data, and clinical inputs to generate meaningful insights and support regulatory reporting.
Strengthen your post-market surveillance framework with integrated data, structured reporting, and global compliance alignment.
Post-market surveillance is one part of post-market compliance. Post-market compliance is broader and includes PMS, complaint handling, vigilance, recalls, FSCA, CAPA, PMCF/PMPF, periodic safety reporting, and integration with risk management and design controls.
Key frameworks include EU MDR, EU IVDR, FDA 21 CFR 803/806/820, ISO 13485, ISO 14971, and country-specific requirements in markets such as the UK, Canada, Australia, Japan, China, India, and Brazil.
EU MDR and IVDR require stronger PMS planning, PMSR/PSUR reporting, PMCF/PMPF, trend reporting, and deeper integration with clinical or performance evaluation, risk management, and EUDAMED-related documentation.
Yes. We support pre-launch setup of PMS plans and complaint systems, ongoing post-market operations for commercial products, and sustenance programs for mature or legacy portfolios.
Our integrated model links complaint and vigilance signals to engineering review, CAPA, verification, manufacturing change control, and product improvement activities for faster and more effective closure.
Yes. Engagements can range from focused deliverables for emerging companies to global managed vigilance and hybrid lifecycle support models for large OEM portfolios.
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