Safety does not end with the approval. It begins in the market.
Andreas Ebermann | Senior UX Designer | Teamlead Austria
At Consulteer, Post-Market Surveillance is not a downstream reporting process. It is our preventive safety concept for medical devices after placing on the market – where real-world use first reveals risks.
We do not see PMS as a regulatory obligation, but as an opportunity: to close documentation gaps, identify use errors, and derive robust requirements for further development.
For over 20 years, we have supported manufacturers and companies in integrating market surveillance, usability, and risk management into an audit-ready system – for CE marking, MDR/IVDR compliance, and long-term market stability.
Post Market Surveillance
Targeted safety assurance after placing on the market.
Post-Market Surveillance (PMS) describes the systematic process of monitoring medical devices after they have been placed on the market. The objective is to identify risks at an early stage, maintain an up-to-date benefit-risk evaluation, and demonstrate safe use over the long term – proactively and throughout the entire product lifecycle.
PMS generates reliable real-world knowledge about products in the market and is a key requirement under MDR and IVDR.
Focus areas include:
Market feedback and complaints
Vigilance and safety-related incidents
Insights to improve usability for users and patients
Corrective and preventive actions to ensure quality and compliance
Requirements arising from MDR and IVDR
Our Services
PMS System & Strategy
PMCF & Clinical Follow-Up
PMS Reports and Audit Support
Usability-driven Market Surveillance
Trusted Partnerships.
PMS in Practice at Consulteer
From the field back into development
Many risks do not become visible during design review but only in real-world use. Devices are applied differently than intended, clinical workflows evolve, users establish new routines, and unforeseen use cases emerge.
We systematically analyze:
Service and complaint data to identify use errors and relevant trends
Critical use scenarios in everyday clinical practice
Interfaces between the device, IFU, training, and software
Existing documentation, evidence gaps, and necessary corrective and preventive actions
We assess PMS in the context of all relevant stakeholders – manufacturers, competent authorities, Notified Bodies, and internal quality teams – ensuring that findings from the field are translated into meaningful product and process improvements.
Responsibility begins after Approval.
Post-Market Surveillance is an ongoing obligation. It supports medical devices throughout their lifecycle – across updates, product variants, and market expansions.
We view PMS as an opportunity: to strengthen safety, enhance usability, and ensure sustainable regulatory compliance. If you are seeking a partner who goes beyond documentation and establishes PMS as an effective, fully integrated system, we welcome the opportunity to connect with you.
Contact us to ensure robust post-market oversight of your medical device. Precise. Audit-ready. Practice-driven.
