The Art of Post-Market Surveillance in MedTech

The Art of Post-Market Surveillance in MedTech

• Launching Your Product in the Market (Introducing the product to the market, setting expectations and goals, preparing for post-market activities)

• The Importance of Post-Market Surveillance (Defining PMS and its objectives, regulatory requirements and standards, benefits of effective PMS for MedTech companies)

• Implementing PMS Processes (Establishing data collection and reporting systems, monitoring product performance and user feedback, conducting regular assessments and audits, collaborating with cross-functional teams)

• Lifecycle Management and Sustaining Engineering (Identifying areas for improvement and optimization, implementing updates and enhancements, ensuring long-term product viability and competitiveness)

• Categorizing and Addressing Use Errors and Problems (Developing a systematic approach to categorization, avoiding the pitfalls of the "Other" category, implementing corrective and preventive actions (CAPAs), communicating with stakeholders and regulatory bodies)

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