Post‑Market Surveillance (PMS) for Medical Devices and In Vitro Diagnostic (IVD) Devices
Ensure long‑term safety. Maintain global compliance. Strengthen product performance.
Masuu Global Solutions provides comprehensive Post‑Market Surveillance (PMS) support for medical devices and IVDs, enabling manufacturers to meet regulatory expectations throughout the entire product lifecycle. Our tailored PMS solutions cover everything from PMS planning to PSUR, PMSR, and PMCF/PMPF documentation—ensuring continuous monitoring of real‑world performance and regulatory‑ready reporting.
PMS for Medical Devices & IVDs – Overview
Our end‑to‑end PMS services help manufacturers achieve ongoing compliance under key global regulations including:- EU MDR (2017/745)
- EU IVDR (2017/746)
- FDA post‑market reporting requirements
- Global vigilance frameworks
We support PMS plan development, data analysis, clinical/performance follow‑ups, and annual maintenance to ensure devices continue to meet safety, performance, and benefit‑risk expectations.
Masuu’s End‑to‑End PMS Services
- Post‑Market Surveillance (PMS) Plan Development We create customized PMS Plans for both medical devices and IVDs, aligned with:
- EU MDR/IVDR requirements
- Your internal SOPs
- Device risk classification & intended use
- Post‑Market Surveillance Report (PMSR) (For Class I medical devices & Class A IVDs) Our PMSR services include:
- Comprehensive data collection & analysis
- Assessment of real‑world safety and performance
- Identification of emerging risks
- Documentation prepared in full regulatory compliance
- Periodic Safety Update Report (PSUR) (For Class IIa, IIb, III devices & Classes B, C, D IVDs) Masuu compiles PSURs integrating:
- PMS findings
- Adverse event and vigilance data
- Market feedback
- Literature updates
- Risk‑benefit evaluation
- Proactive and reactive data collection
- Post‑Market Clinical Follow‑Up (PMCF) / Performance Follow‑Up (PMPF) PMCF (MDR) and PMPF (IVDR) are essential for demonstrating ongoing clinical/performance evidence. Masuu supports:
- PMCF/PMPF plan development
- Survey and registry‑based follow‑ups
- Real‑world performance data collection
- Long‑term safety & effectiveness evaluation
- Analysis of known & unknown risks
- Continuous verification of intended use
- Annual Maintenance & Lifecycle Reporting We manage annual PMS‑related updates including:
- PMCF/PMPF updates
- PSUR updates
- PMS Plan revisions
- Device performance and risk‑benefit reassessments
- Gap corrections based on regulatory changes
Masuu’s PMS Services Menu
- Post‑Market Surveillance (PMS)
- Periodic Safety Update Report (PSUR)
- PMCF / PMPF documentation
- PMSR development and updates
Masuu’s Tailored PMS Support
SOP Writing for PMS Activities
Masuu develops customized Standard Operating Procedures aligned with regulatory expectations and your organizational processes. Our SOPs ensure:- Consistent PMS activities
- Clear workflows
- Higher data quality
- Seamless regulatory submissions
- Effective internal audit readiness
Full‑Time Employee (FTE) Support
Need ongoing PMS manpower?Masuu provides dedicated FTE resources, including:
- PMS specialists
- Regulatory writers
- Data analysts
- Vigilance experts
Frequently Asked Questions
Post-market surveillance (PMS) is the systematic process of collecting, reviewing, and analyzing information about a medical device or IVD after it enters the market. It helps manufacturers monitor safety and performance, identify emerging risks, evaluate complaints and incidents, and determine whether corrective or preventive actions are needed.
PMS helps manufacturers continuously evaluate the safety and performance of products under real-world conditions. It can reveal previously unidentified risks, recurring complaints, changes in device performance, or emerging safety concerns. The resulting information can support risk management, regulatory reporting, corrective actions, and updates to technical and clinical documentation.
A PMS system can collect information from multiple sources, including customer complaints, adverse events, incident reports, product returns, corrective actions, field safety information, literature, clinical or performance data, and other relevant market feedback. The collected information is analyzed to identify trends, safety signals, and changes that may affect the device’s risk profile.
PMS principles apply to both medical devices and IVDs, but the information being monitored can differ according to the product’s intended purpose and performance characteristics. Medical device surveillance may emphasize clinical safety and device performance, while IVD surveillance can also focus on analytical and clinical performance, test results, complaints, and emerging performance-related issues.
PMS provides real-world information that can be used to reassess known risks and identify previously unrecognized risks. Manufacturers can feed relevant surveillance findings into their risk management processes, evaluate whether existing risk controls remain effective, and determine whether changes to the risk-benefit assessment, labeling, design, or other controls are necessary.
A PMS plan generally defines the information sources to be monitored, methods for collecting and analyzing data, responsibilities, review frequency, and criteria for identifying significant trends or safety signals. It should be appropriate to the device, its risks, intended purpose, and applicable regulatory requirements, with appropriate links to vigilance and risk-management activities.
Complaints and adverse events provide important post-market information about how a device performs in actual use. Manufacturers review these reports to determine whether an event is reportable, whether similar events are occurring repeatedly, and whether investigation or corrective action is necessary. Significant findings can also influence risk management and regulatory reporting.
PMS helps manufacturers meet ongoing regulatory obligations after market authorization or certification. Depending on the applicable framework, surveillance activities may support PMS reports, periodic safety documentation, vigilance reporting, trend reporting, corrective actions, and updates to technical documentation. Continuous monitoring also helps demonstrate that safety and performance remain appropriately controlled throughout the product lifecycle.
PMS findings can identify recurring product issues, process weaknesses, usability concerns, or emerging risks that may not have been evident before commercialization. Manufacturers can use these findings to support CAPA, product improvements, labeling changes, risk-control updates, manufacturing improvements, and other lifecycle decisions based on real-world evidence.
PMS is the broader system for continuously collecting and evaluating post-market information. Vigilance focuses on responding to reportable incidents and significant safety issues, while corrective actions address identified problems. These activities are interconnected: PMS can identify signals, vigilance can trigger regulatory reporting, and investigations may lead to CAPA or field safety corrective actions when appropriate.