Stay Compliant. Stay Informed. Keep Your Device on the Market.

Clearance is the beginning — surveillance is the ongoing commitment. We build PMS systems that are genuinely protective, covering EU MDR, FDA, and CDSCO obligations from the day your device is cleared.

The Problem We Solve

Regulatory clearance does not end your compliance obligations — it begins a new set of them. EU MDR, FDA, and CDSCO all require active post-market surveillance, adverse event reporting, and periodic safety assessments. Companies that treat PMS as an administrative task face warning letters, device suspensions, and CE certificate withdrawals. We build PMS systems that are genuinely protective — not performative.

What We Do

Four PMS disciplines — designed to protect patients, satisfy regulators, and inform product improvement.

📊 Post-Market Surveillance Planning

PMS Plan development per EU MDR Annex III requirements
Proactive and reactive PMS data source definition
Literature surveillance and complaint data integration
Periodic Safety Update Report (PSUR) preparation and submission
Post-Market Clinical Follow-Up (PMCF) plan and study design

⚠️ Adverse Event Reporting & Vigilance

FDA Medical Device Report (MDR) preparation and filing
EU EUDAMED registration and serious incident reporting
CDSCO adverse event reporting and periodic returns
Vigilance report preparation and submission management
Signal detection and trend analysis against defined thresholds

📋 Complaint Handling System

Complaint intake, classification, and documentation workflows
Investigation process and root cause analysis
Regulatory reportability determination
CAPA initiation, tracking, and verification of effectiveness
Field Safety Corrective Action (FSCA) planning and execution support

🔄 PMS as a Managed Service

Ongoing complaint review and monthly PMS reporting
Annual PSUR preparation and Notified Body submission
Continuous literature surveillance program
EUDAMED maintenance and periodic update filings
Escalation management for serious incidents

Who This Is For

Any company with a cleared or certified device has active PMS obligations — we help you meet them.

Any company with a device cleared or certified in the EU, US, or India — PMS obligations begin at clearance

Companies approaching CE re-certification who need documented PMS data as evidence

Firms that have received Notified Body findings related to insufficient PMS activity

Device makers with active field complaints requiring structured investigation and reporting

Why 369 Innovations

We approach post-market surveillance as a clinical feedback system — not a compliance task. Every complaint, every field report, and every literature signal is an input that informs product improvement. That orientation is what regulators expect and what patients deserve.

Key Differentiator: PMS as a clinical feedback system — not a compliance checkbox.