Adverse Event Reporting Services & Solutions
Get expert support for adverse event intake, reportability assessment, MDR and vigilance submissions, and post-market governance. Elexes helps medical device and diagnostics teams meet FDA, EU MDR, IVDR, TGA, and Health Canada obligations with defensible documentation, faster triage, and compliant reporting workflows.
Our Adverse Event Reporting Services
Comprehensive support for intake, assessment, submission, and post-market reporting compliance across major regulatory frameworks.
Reportability Assessment
Structured evaluation of complaints, malfunctions, and safety events against FDA MDR, EU vigilance, IVDR, TGA, and other reporting thresholds to determine if a report is required and document the rationale.
MDR Submission Support
Hands-on preparation of adverse event reports, deficiency-ready narratives, and supporting documentation to help manufacturers submit complete, timely, and defensible reports to applicable authorities.
Complaint Governance
Ongoing oversight of complaint intake, classification, investigation quality, closure records, and escalation pathways so reportable events are identified consistently and managed within required timelines.
PMS Integration
Connect adverse event reporting with post-market surveillance, trend analysis, CAPA, and risk management so safety signals are not siloed and regulatory outputs remain aligned.
Regulatory Response
Support for responding to authority questions, follow-up requests, and enforcement-related communications tied to adverse event submissions or complaint handling practices.
Virtual RAQA Support
Embedded external RAQA support for manufacturers needing continuous oversight of reportability decisions, submission workflows, documentation control, and post-market compliance operations.
Our Adverse Event Reporting Process
Review the incoming event record
We examine the complaint, malfunction, or safety event for completeness, product linkage, seriousness, and available evidence. This first review helps separate routine quality issues from events that may trigger formal adverse event reporting obligations.
Assess reportability against regulations
Our consultants evaluate the event against the applicable framework, including FDA 21 CFR Part 803, EU MDR vigilance rules, IVDR Article 82 expectations, and other market-specific criteria. We document the rationale clearly so your decision trail is audit-ready.
Prepare the required submission package
If the event is reportable, we draft the report narrative, compile supporting details, align dates and device information, and structure the submission for the relevant authority. The goal is a complete, defensible filing with fewer follow-up questions.
Coordinate submission and follow-up
We support timely filing, track deadlines, and help manage any authority responses or requests for clarification. This keeps your team organized while reducing the risk of missed timelines or inconsistent follow-up documentation.
Feed outcomes into PMS and CAPA
After submission, we help connect the event to complaint trending, risk management updates, CAPA, and post-market surveillance reporting. That integration strengthens your overall quality system and supports ongoing regulatory compliance.
Trusted By Manufacturers
Success Stories
Supporting global medical device teams with compliant reporting, stronger governance, and audit-ready post-market systems.
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“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.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“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.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“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.”
Elizabeth W
“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, defensible post-market regulatory support.
Deep Expertise
50+ years of collective experience across FDA, EU MDR, IVDR, TGA, and global frameworks.
End-to-End Support
From complaint intake to report submission and PMS integration, Elexes supports the full lifecycle.
Audit Readiness
Structured documentation and defensible rationales help strengthen inspections, audits, and authority follow-up responses.
Flexible Delivery
Choose project-based, part-time, or embedded RAQA support without adding permanent internal headcount.
Meet The Elexes Team
Experienced regulatory specialists supporting complex post-market obligations.
Elexes Medical Consulting Pvt. Ltd. supports medical device, diagnostics, and digital health companies with practical regulatory and quality expertise across the full product lifecycle. The team has built a strong reputation for helping manufacturers navigate complex global requirements, from premarket strategy through post-market surveillance and adverse event reporting. With 50+ years of collective experience, Elexes combines regulatory, quality, and clinical insight to deliver documentation that stands up to scrutiny. Their consultants support organizations ranging from startups to established global manufacturers, acting as strategic advisors or embedded operational partners. The focus is always the same: reduce compliance risk, improve submission quality, and help clients maintain market access with confidence.
200+ Product TypesExperience spanning diverse device categories and technologies.90% Audits ClearedStrong track record supporting inspection and audit readiness.250+ Successful ProjectsDelivered across regulatory, quality, and post-market engagements.
Frequently Asked Questions
What are the FDA requirements for reporting adverse events?
For medical devices, FDA adverse event reporting is primarily governed by 21 CFR Part 803. Manufacturers must evaluate complaints, deaths, serious injuries, and certain malfunctions to determine reportability, submit Medical Device Reports within required timelines, maintain event files, and document the rationale for reportable and non-reportable decisions. Complaint handling under 21 CFR Part 820 also needs to align with these reporting obligations.
What are the four minimum criteria for reporting an adverse event?
The four minimum criteria generally include an identifiable patient, an identifiable reporter, a suspect device or product, and an adverse event or outcome that can be reasonably described. If those core elements are present, the case usually requires formal evaluation for reportability. Manufacturers should also document missing details, follow up for additional information, and preserve a clear assessment trail.
How quickly do adverse events need to be reported?
Reporting timelines depend on the jurisdiction and event type. Under FDA MDR rules, certain events must be reported within 30 calendar days, while some situations may require 5-day reporting. EU and other global frameworks also impose strict vigilance deadlines based on seriousness and public health risk. A reliable intake and triage process is essential to avoid missed deadlines.
What is the difference between a complaint and an adverse event?
A complaint is any written, electronic, or oral communication alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance. An adverse event is a subset of complaints involving death, serious injury, malfunction, or other reportable safety concerns. Not every complaint is reportable, but every complaint should be assessed to determine whether adverse event reporting obligations apply.
Do malfunctions have to be reported even if no one was harmed?
Yes, in many cases they do. Under FDA MDR requirements, a malfunction may be reportable if it would be likely to cause or contribute to a death or serious injury if it recurred. That means manufacturers must assess not only actual harm, but also the potential severity of a repeat event. Clear malfunction definitions and documented decision logic are critical.
What documentation should support an adverse event reportability decision?
A defensible decision file should include the original complaint record, event description, device identification, investigation findings, seriousness assessment, reportability rationale, applicable regulatory references, submission dates if reported, and follow-up actions. It should also show how the event connects to CAPA, risk management, and PMS where relevant. Regulators expect consistency, traceability, and timely closure across the full record.
Can Elexes support global adverse event reporting beyond the FDA?
Yes. Elexes supports manufacturers working across FDA, EU MDR, IVDR, TGA, Health Canada, and other international frameworks. That includes reportability assessments, vigilance submissions, complaint governance, PMS integration, and authority response support. This is especially valuable for companies managing the same product family across multiple markets with different reporting thresholds and timelines.
How can outsourced RAQA support improve adverse event compliance?
Outsourced RAQA support gives manufacturers access to experienced regulatory and quality professionals without building a full in-house team. An embedded partner can review incoming complaints, assess reportability, prepare submissions, maintain documentation, and connect events to PMS and CAPA workflows. This improves consistency, reduces internal bottlenecks, and helps organizations stay compliant during growth, audits, or resource gaps.
Still Have Reporting Questions?
Talk with our regulatory experts about your reporting obligations.
Certified & Trusted
Awards and Recognition
ISO 13485
Medical device quality system expertise.
MDSAP
Supports multi-market audit readiness.
IEC 62304
Software lifecycle compliance knowledge.
