Post Market Surveillance for Medical Devices

Turn Data into Monthly Decisions

Complaints, vigilance inputs, and post-market data often sit across multiple systems without leading to clear, documented monthly decisions. Our Post-Market Intelligence Retainer converts fragmented PMS data into trend insights, CAPA triggers, risk actions, and audit-ready outputs.

The Problem: PMS Data Exists, But Decisions Don’t

Most medical device companies already have post market surveillance systems in place.

They collect:

⦿ Complaints

⦿ Adverse event data

⦿ Vigilance reports

⦿ Field feedback

But the real issue is this:

Your data is not translating into actionable, defensible decisions.

PMS becomes a documentation burden rather than a decision-making system.

What Teams Struggle With

Organizations commonly encounter challenges in the following areas:

⦿ Distinguishing true trends from background variation

⦿ Defining appropriate thresholds for signal detection

⦿ Substantiating decisions during audits

⦿ Establishing a clear linkage between complaint data, CAPA, and risk management

⦿ Producing PMS reports that are clear, justified, and audit-ready

Result:
PMS often becomes a compliance-driven activity, with emphasis on documentation rather than enabling informed product or quality decisions.

Who This Is For

This service is designed for:

⦿ Quality & Regulatory Head

⦿ Regulatory Affairs Director

⦿ Post-Market Surveillance Lead

⦿ Complaint Handling Lead

⦿ PMS / Vigilance Manager

⦿ RA/QA Heads in EU MDR-driven organizations

Ideal for Companies With

⦿ Increasing complaint volumes

⦿ Multiple marketed devices

⦿ EU MDR PMS or PSUR pressure

⦿ Weak PMSR / PSUR documentation

⦿ Audit findings in complaint handling or PMS

What This Service Delivers

We convert your post-market surveillance medical device data into the following:

⦿ Trend analysis

⦿ Signal detection outputs

⦿ CAPA actions

⦿ Risk management updates

⦿ Audit-ready documentation

⦿ Documented decision logic

Why This Matters

Post-market surveillance requirements do not stop at data collection - they require defensible, traceable decisions.

What This Service Is Not

⦿ Not a one-time PMS plan creation

⦿ Not limited to the complaint handling setup

⦿ Not only PSUR or PMSR writing

This is an ongoing intelligence system, not a document service.

What Data Sources Do We Work With

“We work with your existing PMS and complaint data sources, so a full system overhaul is not required to get started.

Typical Inputs

A structured PMS system usually draws from multiple inputs, such as:

⦿ Complaint handling records

⦿ Adverse event and reportability logs

⦿ CAPA data

⦿ Field service and maintenance reports

⦿ Product return and failure analysis

⦿ Internal trend trackers or spreadsheets

⦿ PMS plans and periodic reports

⦿ Risk management documentation

What to Expect After Month 1

Month 1: Foundation & Setup

⦿ PMS maturity assessment

⦿ Data structure and mapping

⦿ Set up the trending framework

⦿ Decision logic definition

Month 2 onward: Monthly Intelligence & Decision Support

⦿ Monthly trend analysis

⦿ Signal detection

⦿ Decision recommendations

Later Phase: Deeper CAPA, Risk, and PSUR/PMSR Integration

⦿ Strong CAPA linkage

⦿ Risk file updates

⦿ PSUR / PMSR justification improvement

Decision Outputs We Help You Create

Every month, we help you document decisions such as:

⦿ Trend/No Trend

⦿ Signal/No Signal

⦿ CAPA/No CAPA

⦿ Risk Update/No Update

⦿ Need for deeper investigation

⦿ PMSR/PSUR justification

These outputs directly support PMSR, PSUR, and broader post-market decision documentation requirements.

What Companies Usually Miss

⦿ Decisions are taken, but not captured clearly

⦿ Trend thresholds are not defined

⦿ Data is reviewed, but interpretation is inconsistent

⦿ Complaint data does not properly connect to CAPA or risk

⦿ Reports are created, but they don’t lead to action

Regulatory Alignment

We help align your PMS approach with:

⦿ EU MDR PMS/PSUR expectations

⦿ FDA post-market and complaint-handling requirements, and

⦿ Relevant ISO 13485 clause

Deliverables

⦿ Monthly PMS Intelligence Report

⦿ Complaint Trending Dashboard

⦿ Signal Detection Summary

⦿ CAPA Recommendation Log

⦿ Risk Impact Notes

⦿ PMSR / PSUR support

⦿ Audit-ready documentation

⦿ Decision tracking register

What Elexes Does

This is not a one-time PMS activity.

We go beyond:

⦿ PMS plan creation

⦿ PSUR / PMSR writing

⦿ Complaint data review

We provide ongoing monthly intelligence and decision support that ensures your post-market surveillance system continuously drives actions, not just reports.

Assessment

We start by reviewing how your current PMS system operates, including:

⦿ Complaint handling processes

⦿ Vigilance and reporting workflows

⦿ Data completeness and structure

Gap Analysis

We review your current setup and identify gaps in:

⦿ Trend analysis and statistical support

⦿ Signal detection frameworks

⦿ Documentation

⦿ Regulatory alignment (FDA & EU MDR)

Strategy

We define a structured PMS intelligence framework, including:

⦿ Data aggregation logic

⦿ Trending thresholds

⦿ Signal detection criteria

⦿ Decision-making logic

⦿ Reporting frequency

Documentation

We strengthen documentation to support clearer and more efficient decision-making, including:

⦿ PMS Plan aligned with actual execution

⦿ PMSR / PSUR structuring with clear justification

⦿ Signal evaluation and trend documentation templates

Execution

This is where the real value lies.

Every month, we:

⦿ Evaluate newly received PMS data

⦿ Detect trends and potential signals

⦿ Provide documented decision recommendations

⦿ Propose CAPA measures when necessary

⦿ Assist in updating risk documents

Ongoing Decision Support

We help ensure your PMS system consistently answers:

⦿ Is there a trend or not?

⦿ Is there a signal or not?

⦿ Does this require CAPA?

⦿ Does risk need to be updated?

⦿ Is further investigation required?

All decisions are:

⦿ Clearly documented

⦿ Evidence-based and clearly documented

⦿ Audit-ready

Why This Matters

Without a structured PMS approach, issues tend to show up quickly:

⦿ Safety signals may be missed

⦿ FDA inspections may raise observations

⦿ EU MDR non-conformities can occur

⦿ PSUR justification may be weak

⦿ CAPA actions get delayed

⦿ The risk of delayed field action or recall decisions increases

Why Elexes

⦿ Global regulatory expertise (FDA, EU MDR, UKCA, Health Canada)

⦿ Experience across SaMD, IVD, and hardware

⦿ Strong ISO 13485 understanding

⦿ Senior expert-led execution

⦿ Proven audit readiness support

We do not stop at PMS reports – we help connect complaint trends, CAPA logic, and risk decisions into a usable monthly system.

How We Supported Our Clients

Device Type: Diagnostic Device

Problem: Complaint and post-market data were being collected, but there was no consistent framework for trend detection or decision-making.

Work: Elexes implemented a monthly PMS intelligence model with defined trend logic, documented decision outputs, and clearer CAPA linkage.

Outcome:

⦿ Earlier visibility into trends

⦿ More timely CAPA initiation, and

⦿ Improved readiness for EU MDR audit review.

What Happens Next

⦿ 30-minute discovery call ⦿ PMS maturity assessment ⦿ Custom PMS support roadmap

Identify gaps in trend analysis, PSUR support, and complaint handling

Click here to get the PMS Readiness Checklist

FAQs

Frequently Asked Questions!

What is post-market surveillance for medical devices?

It is the ongoing process of collecting and evaluating complaints, safety, and market data after launch to identify trends, risks, and required actions.

Do you support alignment with FDA and EU MDR requirements?

Yes. We support clients in aligning their PMS approach, documentation, and decision logic with FDA and EU MDR expectations.

Can you work with our current complaint system?

Yes. We work with your existing data sources.

Do you support PSUR and PMSR?

Yes. We support both structure and justification.

What data do we need to provide?

Complaint, CAPA, vigilance, and risk data.

Can you support audits?

Yes. We support audit readiness by strengthening PMS documentation, decision logic, and supporting responses where needed.

Do you act as a PMS specialist?

Yes. We can function as an extended PMS support team, working with your existing systems and internal stakeholders.

Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Why choose

Elexes for medical device regulatory & compliance services?

Quick Turn around

Experience timely results with our efficient services.

Confidentiality guaranteed

We offer 100% confidentiality understanding how critical the data is for you.

Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!

So, if you are looking for a consultancy with deep expertise, experience, and established relationships with regulatory authorities, which can significantly enhance a company's regulatory journey and increase the likelihood of successful product registration and market access, all you have to do is

Request a Consultation

Our New Product Approval Service Corner

We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

Associated Regulatory Authorities.

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Than 256+ Global Clients

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Clients Testimonials

Amazing Feedback About Our Services

Tom Birney

CEO Masterlink, Arizona

^“ Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms _“

Diane Bryant

CEO Novasignal, Los Angeles

^“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. _“

Daniel Kinsey

President ViDava, Florida

^“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice. _“

Linda Pan

Sr. Exe Treedental, Hong Kong

^“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. _“

Joshua Mink

Manager Outset Medical, California

^“Highly recommend Elexes! They always meet commitments and follow through on action items. _“

Michal Depa

CTO Jana Care, Massachusetts

^“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly. _“

Philip McFerran

MD Blackrock Pharma, England

^“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. _“

Samip Shah

VP Regulatory AliveCor, California

^“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. _“

Elizabeth W

Owner Liz Inc., Arizona

^“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time. _“