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Post-Market Surveillance

Ongoing compliance, vigilance, safety monitoring, reporting, and lifecycle support after market authorization.

Built for Products Already on the Market

We help manufacturers maintain compliance after authorization through structured PMS, vigilance, reporting, and lifecycle controls.

Authorized Manufacturers

Keep post-market obligations aligned with SFDA, GCC, and international expectations.

Quality Teams

Connect complaints, CAPA, trend data, and PMS outputs into a compliant operating system.

Regional Distributors

Clarify reporting duties, escalation timelines, and local post-market communication workflows.

Portfolio Managers

Monitor safety signals and lifecycle changes across multiple authorized devices.

Post-Market Control For Ongoing Compliance

We turn post-authorization obligations into practical monitoring, reporting, and improvement workflows.

PMS Plan Development

We build surveillance plans that define data sources, responsibilities, review cadence, and reporting expectations.

Vigilance & Incident Reporting

We support assessment, escalation, and reporting of adverse events, complaints, and safety concerns.

Trend & Signal Review

We help analyze complaints, service data, CAPA trends, and emerging risks for actionable insights.

Lifecycle Change Control

We assess product, labeling, supplier, and process changes for regulatory impact after authorization.

Periodic Compliance Support

We support PMS summaries, management review inputs, renewals, and ongoing authority readiness.

How We Work

A controlled process for keeping authorized devices compliant, monitored, and ready for regulatory review.

Monitor

Collect complaints, field data, service inputs, and safety information.

Assess

Evaluate severity, recurrence, reportability, and regulatory impact.

Report

Prepare vigilance, authority, or internal compliance reports when needed.

Improve

Feed PMS findings into CAPA, risk management, and product updates.

Maintain

Keep lifecycle files, renewals, and authority readiness current.

Key Deliverables

Clear outputs that drive compliance, reduce risk, and accelerate your time to market.

01

PMS Plan

A structured surveillance plan defining scope, data sources, and responsibilities.

02

Vigilance Assessment Notes

Clear evaluation of incidents, reportability, and escalation requirements.

03

Trend Review Summary

Periodic analysis of complaints, safety signals, and recurring field issues.

04

Lifecycle Impact Memo

Assessment of product or process changes and their regulatory consequences.

05

Compliance Maintenance Roadmap

Prioritized post-market actions for continued authorization readiness.

Build a Complete Regulatory Ecosystem .

LexoraMed provides integrated regulatory support across Saudi Arabia, GCC, and global markets — helping manufacturers move from strategy to authorization with confidence and clarity.

Medical Device Market Authorization

Advisory on securing MDMA, SFDA approvals, and global authorization pathways for regional and international market entry.

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Technical File Assessment

Leading comprehensive reviews of innovative device dossiers, successfully translating advanced clinical data, cybersecurity parameters, and biocompatibility profiles into robust regulatory submissions.

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Post-Market Surveillance

Ongoing compliance, vigilance, safety monitoring, reporting, and lifecycle support after market authorization.

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Frequently Asked Questions

Clear answers to the most common regulatory and compliance questions manufacturers ask before entering Saudi Arabia and global markets.

When does post-market surveillance begin? +
PMS begins once a device is placed on the market, but the plan should be prepared before launch so responsibilities and reporting routes are clear.
Is PMS only about adverse event reporting? +
No. PMS also includes complaint trending, CAPA inputs, risk updates, lifecycle changes, periodic reviews, and authority readiness.
Can distributors support post-market surveillance? +
Yes, but responsibilities must be clearly defined so complaints, incidents, and safety signals are escalated to the manufacturer correctly.
Do PMS findings affect future approvals? +
Yes. PMS outputs can affect renewals, technical file updates, risk management, labeling changes, and future market authorization decisions.