Periodic Safety Update Reports Compliance Services
Stay ahead of EU MDR post-market obligations with expert support for Periodic Safety Update Reports (PSURs). Elexes helps medical device manufacturers compile defensible safety data, trend analyses, and benefit-risk evaluations that satisfy Notified Body and competent authority expectations while reducing delays, internal workload, and compliance risk across global portfolios.
Our PSUR Compliance Services
Targeted support for PSUR preparation, post-market governance, and regulatory compliance across the medical device lifecycle.
PSUR Preparation
End-to-end support for drafting and compiling Periodic Safety Update Reports, including safety summaries, benefit-risk evaluations, PMS outputs, and documentation aligned with EU MDR expectations.
PMS Governance
Structured oversight for complaint handling, surveillance data review, signal detection, and integration of post-market findings into PSURs and related compliance activities.
Reportability Support
Expert assessment of adverse events, malfunctions, and vigilance obligations to ensure reportable issues are evaluated correctly and reflected in post-market documentation.
Risk File Alignment
Alignment of PSUR conclusions with risk management files, clinical evaluations, CAPA records, and broader technical documentation for a coherent regulatory position.
Complaint Trending
Analytical review of complaint and field data to identify trends, emerging safety signals, and recurring issues that must be addressed in periodic safety reporting.
Virtual RAQA Support
Embedded regulatory and quality support for manufacturers needing ongoing PSUR management, documentation control, and post-market compliance oversight without added headcount.
Post-Market Expertise
Defensible PSUR Support That Reduces Risk
Periodic Safety Update Reports require more than assembling data. Elexes helps manufacturers turn complaint records, vigilance inputs, PMS findings, and benefit-risk assessments into clear, regulator-ready PSURs. Our team supports the full reporting cycle, strengthens traceability across quality and clinical records, and helps ensure your post-market documentation stands up to EU MDR scrutiny without overburdening internal teams.
Trusted By Manufacturers
Success Stories
Supporting medical device teams with compliant reporting and stronger post-market documentation.
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
The Elexes Difference
Why Choose Elexes?
Manufacturers rely on Elexes for practical, high-accountability regulatory support across complex post-market obligations.
Deep Expertise
50+ years of collective experience across regulatory, quality, and post-market medical device compliance.
End-to-End Support
From PMS inputs to final PSUR delivery, Elexes supports the full reporting and compliance workflow.
Global Coverage
Experience across EU MDR, FDA, Health Canada, TGA, and other major regulatory frameworks.
Flexible Resourcing
Scale support through project-based, part-time, or embedded RAQA models without increasing headcount.
Meet The Elexes Team
Experienced specialists in medical device regulatory compliance.
Elexes Medical Consulting Pvt. Ltd. supports medical device manufacturers with specialized regulatory, quality, and post-market compliance expertise. Over the years, the company has become a trusted consulting partner for organizations navigating approvals, technical documentation, QMS support, and lifecycle compliance obligations. For PSUR services, Elexes brings together regulatory, quality, and surveillance knowledge to help manufacturers build reports that are accurate, traceable, and defensible. The team works across global frameworks including EU MDR, FDA, TGA, and Health Canada requirements, helping clients reduce submission risk and maintain market continuity. With a practical, execution-focused approach, Elexes acts as an extension of internal teams to keep post-market obligations on track.
200+ Product TypesExperience spanning a wide range of medical technologies.90% Audits ClearedStrong track record in inspection and audit readiness.250+ Successful ProjectsDelivered across diverse regulatory and compliance engagements.
Frequently Asked Questions
What is a periodic safety update report?
A periodic safety update report, or PSUR, is a formal post-market surveillance document required under EU MDR for certain medical devices. It summarizes complaint data, vigilance events, trend analysis, corrective actions, sales or usage information, and the current benefit-risk determination. The report shows regulators and Notified Bodies that the manufacturer is actively monitoring device safety and performance after market placement.
Who is required to submit a periodic safety update report?
Under EU MDR, manufacturers of Class IIb and Class III medical devices are generally required to prepare PSURs, while Class IIa devices typically require a post-market surveillance report instead. The exact obligation depends on device classification, market status, and applicable regulatory pathways. Manufacturers must ensure the report is updated at the required frequency and made available to the relevant authorities or Notified Body.
What information should be included in a PSUR?
A PSUR should include the conclusions of the benefit-risk determination, main findings from post-market surveillance data, complaint and vigilance summaries, trend reporting outcomes, CAPA-related insights, and relevant sales or population exposure data. It should also explain any preventive or corrective actions taken. The content must be consistent with your PMS plan, risk management file, and clinical evaluation documentation.
How often does a PSUR need to be updated?
For Class III and implantable devices, PSURs are generally updated at least annually. For Class IIb devices, the frequency is typically at least every two years unless a different interval is justified by the applicable requirements. Manufacturers should confirm the reporting cadence based on device classification, certification status, and Notified Body expectations, then maintain a documented schedule to avoid missed compliance deadlines.
How is a PSUR different from a PMS report?
A PMS report is usually prepared for Class I and Class IIa devices and provides a summary of post-market surveillance findings. A PSUR is more detailed and is required for higher-risk devices, especially Class IIb and Class III. It includes deeper analysis of safety and performance data, benefit-risk conclusions, and a stronger linkage to vigilance, CAPA, and risk management activities.
What are common PSUR compliance mistakes manufacturers make?
Common issues include incomplete complaint trending, weak linkage between PMS findings and risk files, outdated benefit-risk assessments, inconsistent data across quality records, and reports that simply summarize events without meaningful analysis. Another frequent problem is treating the PSUR as a standalone document instead of integrating it with CAPA, clinical evaluation, vigilance reporting, and post-market governance processes required under EU MDR.
Can Elexes help if our complaint and PMS data are not well organized?
Yes. Elexes can review your existing complaint records, PMS outputs, reportability decisions, and supporting quality documentation to identify gaps before PSUR drafting begins. The team helps structure the data, improve traceability, and align findings with risk management and clinical records. This makes the final report more coherent, more defensible, and easier to support during audits or Notified Body review.
Do PSUR services only apply to EU MDR devices?
PSURs are primarily an EU MDR obligation, but the underlying work often overlaps with broader global post-market compliance activities. Complaint handling, vigilance assessment, trend analysis, CAPA linkage, and risk file updates also support FDA, TGA, Health Canada, and other regulatory expectations. A well-managed PSUR process can therefore strengthen your overall post-market governance, not just your EU documentation.
Still Need PSUR Guidance?
Speak with our regulatory experts about your reporting obligations.
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Awards and Recognition
ISO 13485
Medical device quality system expertise
MDSAP
Multi-market audit readiness support
IEC 62304
Software lifecycle compliance knowledge
