Service
Post-Market Support
Post-market activities are vital to maintaining the safety, effectiveness, and compliance of medical devices throughout their lifecycle. Upshot supports manufacturers with continuous monitoring, data-driven updates, and regulatory reporting to ensure long-term product performance and compliance.
Comprehensive Post-Market Surveillance Support
Upshot provides comprehensive post-market support to help medical device manufacturers meet evolving regulatory expectations and maintain product safety, quality, and compliance in the real world. Our services include Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Clinical Evaluation Reports (CER), along with ongoing risk file updates driven by real-world data and user feedback. We help clients identify emerging risks, analyze performance trends, and maintain proactive compliance with standards such as EU – MDR 2017/745, ISO 14971, guidelines—ensuring devices continue to meet clinical, safety, and regulatory requirements long after market launch.
Our Service Includes
Post-Market Surveillance Planning & Reporting
Preparation of Post-Market Surveillance Plans (PMSP) and Post-Market Surveillance Reports (PMSR) in alignment with regulatory expectations.
Risk File Maintenance
Ongoing updates to the risk management file based on real-world post-market data to ensure proactive risk identification and mitigation.
Clinical Evaluation & PMCF Support
Development of Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF) plans and reports in full compliance with EU MDR 2017/745 requirements.
