Post Market Surveillance (PMS) Consulting
Post Market Surveillance (PMS) Consulting Services
Build a Proactive PMS Strategy Before Issues Escalate
As your specialized medical device PMS consulting partner, MDRCert builds defensible post-market systems before field issues escalate. We design your MDR post-market surveillance system and IVDR PMS strategies in strict compliance with the European Medical Device Regulation (MDR) 2017/745 and European In Vitro Diagnostic Regulation (IVDR) 2017/746, turning raw field data into actionable compliance rather than a documentation backlog.
Step-by-Step Execution for Audit-Ready Reporting
We implement practical, end-to-end post-market surveillance consulting tailored to what Notified Bodies expect:
-
PMS & PMCF Planning: Customized strategies aligned with clinical follow-up.
-
Vigilance Management: Systematic workflows for incident reporting and FSCAs.
-
Trend Analysis: Statistical evaluation of field feedback to proactively detect risks.
-
Regulatory Reporting: Authoring review-ready PMSRs and comprehensive PSURs.
Post Market Surveillance Consulting Services
01 - 05
Current-State PMS Gap Assessment
02 - 05
PMS Plan, Metrics, and Governance Design
03 - 05
Data Collection, Trending, and Signal Workflow Setup
04 - 05
PMS Report/PSUR Authoring and Review Readiness
05 - 05
Periodic Update Governance and Continuous Improvement
What Teams Need Before PMS Audit or Regulatory Review
Most teams need three outcomes: complete post-market data traceability, timely signal-to-action governance, and confidence during authority or Notified Body scrutiny.
Our PMS consulting approach aligns QA, RA, clinical, vigilance, and product teams so safety and performance monitoring remains consistent and actionable.
Early Signal Detection
Consistent Signal Evaluation
Defensible Corrective Action Logic
Lifecycle Surveillance Continuity
Need PMS clarity before your next review cycle? Talk to MDRCert.
Core PMS Consulting Coverage Areas
MDRCert Testimonials
Testimonials
Working with MDRCert for our MDR compliance audit was a game-changer. Their thorough risk management assessment helped us achieve Notified Body approval on the ...
Dr. James Rodriguez
MDRCert guided us through our complete IVDR transition with exceptional expertise. Their team identified critical gaps in our technical documentation and provid...
Sarah David
As a first-time manufacturer, the EU MDR felt overwhelming. MDRCert became our trusted partner, guiding us from initial strategy and risk management to final su...
Ben Smith
The gap analysis conducted by MDRCert was a game-changer. They identified critical vulnerabilities in our technical file before our notified body audit. Their a...
Thomas Wright
Implementing a compliant ISO 13485:2016 QMS seemed daunting. MDRCert provided clear, pragmatic guidance tailored to our small company’s needs. They didn&#...
Maria Rodriguez
MDRCert authored a comprehensive Clinical Evaluation Report for our Class IIb device. Their report was exceptionally thorough and meticulously structured, which...
David Chen
We engaged MDRCert for our full MDR transition strategy. Their team’s deep expertise, particularly their former notified body background, was invaluable. ...
Sarah Jenkins
Frequently Asked Questions About PMS Consulting
Need a clear path to compliance? Talk to MDRCert
Tell us about your device, target market, and current stage. We will guide you on the most practical next steps.
MDRCert Regulatory Support Team
Have questions? Contact our team
Still have questions?
Can't find the answer you're looking for? Contact our expert team today.