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Medical Device Services

Quick Snapshot

  • Who Can Apply?
    • Medical Device Manufacturers
    • IVD Manufacturers
    • Contract Manufacturers
    • Startups Developing Medical Devices
    • Companies Expanding into International Markets
  • Services Covered
    • PMS Plan Preparation
    • PMS Report Preparation
    • PMS Procedure Development
    • Complaint Trend Analysis
    • Regulatory Gap Assessment
    • Risk Management Integration
    • Audit Readiness Support
  • Applicable Markets
    • India (CDSCO)
    • European Union (EU MDR / IVDR)
    • United States (FDA)
    • Canada
    • Australia
    • United Kingdom
    • Other International Markets

Post-Market Surveillance (PMS) Plan & Report Support

Post-Market Surveillance (PMS) is the process of continuously monitoring the safety, quality, and performance of a medical device after it has been placed on the market. It helps manufacturers understand how their devices perform in real-world use and identify any issues that may require corrective action.

Regulatory authorities worldwide, including CDSCO (India), US FDA, EU MDR/IVDR, Health Canada, TGA Australia, and other international regulators, expect manufacturers to have systems in place to collect, review, and evaluate post-market information.

A PMS Plan describes how post-market information will be collected, monitored, and assessed. A PMS Report documents the findings from these activities, including trends, complaints, feedback, adverse events, and actions taken to maintain product safety and compliance.

A well-established PMS system helps manufacturers maintain regulatory compliance, improve product quality, support risk management activities, and demonstrate ongoing commitment to patient safety.

When Do You Need PMS Support?

Support for establishing, maintaining, and improving post-market surveillance systems for medical devices and IVDs across regulated markets.

When Do You Need PMS Plan & Report Support?
  • Launching a medical device or IVD in a regulated market
  • Preparing technical documentation for regulatory submissions
  • Applying for CE Marking under EU MDR or IVDR
  • Establishing a post-market surveillance system for the first time
  • Preparing for regulatory inspections or audits
  • Updating risk management and clinical evaluation documentation
  • Managing customer complaints and market feedback
  • Maintaining compliance after product approval or registration
  • Expanding products into new international markets
Key Challenges
  • Understanding country-specific PMS requirements
  • Developing a structured PMS system
  • Identifying appropriate post-market data sources
  • Managing complaint and adverse-event data
  • Linking PMS activities with risk management processes
  • Maintaining inspection and audit readiness
  • Demonstrating continuous product monitoring

Our Approach and What You Will Get

Practical implementation and regulatory compliance support for post-market surveillance systems, documentation, monitoring, and audit readiness.

Our Approach
  • Review of applicable regulatory requirements
  • Assessment of existing PMS processes and procedures
  • PMS Plan and report preparation and/or review
  • Identification of data collection and monitoring methods
  • Complaint and feedback trend analysis
  • Integration of PMS with risk management activities
  • Regulatory compliance support and documentation review
  • Audit and inspection readiness support
What You Will Get (Deliverables)
  • Post-Market Surveillance Plan
  • PMS Report preparation and review
  • PMS procedures and work instructions
  • Complaint-handling process review
  • Trend analysis and data evaluation support
  • PMS and Risk Management linkage assessment
  • Regulatory gap assessment
  • CAPA recommendations arising from PMS activities
  • Audit-ready PMS documentation

Why Choose Tacit Medtek and Case Example

Practical, risk-based support for building sustainable post-market surveillance systems for medical devices and IVDs across global markets.

Why Choose Tacit Medtek?
  • Practical understanding of global medical device regulations
  • Experience supporting medical devices and IVDs
  • Risk-based and compliance-focused approach
  • Support tailored to product type and target market
  • Assistance from documentation preparation through implementation
  • Focus on practical and sustainable compliance solutions
  • Support for startups and established manufacturers
Case Example
  • Challenge: A medical device manufacturer supplying products to multiple international markets had a complaint-handling process in place but lacked a structured Post-Market Surveillance system and documentation to support regulatory compliance.
  • Our Approach: Reviewed existing complaint and feedback management processes; identified gaps against applicable regulatory requirements; developed a risk-based PMS Plan; established data collection and trend-monitoring processes; prepared PMS reporting templates and procedures; and integrated PMS activities with the company’s risk management system.
  • Outcome: The manufacturer implemented a structured PMS process and improved monitoring of product performance and regulatory compliance for customer and regulatory audits.

FAQ

Frequently Asked Questions

01
What is a PMS Plan?

A PMS Plan describes how a manufacturer will collect, monitor, analyse and evaluate post-market information related to a medical device or IVD.

02
Why is Post-Market Surveillance important?

PMS helps manufacturers monitor product performance, identify emerging risks, improve product quality and maintain regulatory compliance.

03
What information is typically reviewed during PMS activities?

Customer complaints, adverse events, service records, returned products, literature reviews, market feedback, and trend data are commonly reviewed.

04
Is PMS required for all medical devices?

Most regulatory authorities expect manufacturers to perform post-market monitoring activities, although documentation requirements may vary by country and device classification.

05
What is included in a PMS Report?

A PMS Report generally summarizes post-market data collected, analysis performed, identified trends, conclusions and any corrective actions taken.

06
How often should PMS activities be performed?

PMS should be an ongoing process throughout the product lifecycle. Reporting frequency depends on regulatory requirements and device risk classification.

07
How does PMS support Risk Management?

PMS data helps verify whether existing risk controls remain effective and whether any new risks have emerged during actual product use.

08
Can customer complaints be used as PMS data?

Yes. Customer complaints are one of the most important sources of post-market information and trend analysis.

09
Do you review existing PMS documentation?

Yes. We can review existing PMS Plans, PMS Reports and related procedures to identify compliance gaps and improvement opportunities.

10
Do you support both Medical Devices and IVDs?

Yes. We provide PMS documentation and compliance support for both Medical Devices and In Vitro Diagnostic Devices (IVDs).

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