Case Study
Pampero Relay
A controlled approach to medical device complaint intake
Pampero Relay is in architecture and validation planning. It is not currently deployed or validated for live complaint handling.
In brief
A supervised conversational intelligence system for medical device complaint intake.
Pampero Relay is a supervised conversational intelligence system being developed to help medical device organisations capture, structure, and route complaint information with greater consistency, capacity, and traceability.
Relay supports the initial collection and organisation of information while keeping safety decisions, regulatory assessments, and final approval under the control of qualified personnel.
This document describes the intended operating model without disclosing the technical architecture, control logic, or deployment methods behind the product.
The operational requirement
A medical device complaint can contain information that affects product quality, patient safety, and regulatory reporting.
The organisation must capture the relevant facts, preserve an accurate record, and identify situations that require immediate attention. Once the intake is complete, qualified personnel must determine whether the event is reportable and what action should follow.
Complaint services must remain available during ordinary demand, unexpected increases in call volume, and potential product recalls. Each conversation must follow an approved process while remaining clear, respectful, and accessible to the caller.
Medical device manufacturers in the United States operate under the FDA Quality Management System Regulation. The regulation became effective on 2 February 2026 and incorporates ISO 13485:2016 into the United States quality framework. It establishes quality management requirements that include the control and review of complaint information.
Separate Medical Device Reporting requirements apply to certain events involving death, serious injury, or device malfunction. Manufacturers must assess the information they receive and report qualifying events within the applicable timeframes.
Accurate complaint intake is therefore more than a customer service function. It contributes directly to patient safety, product quality, and regulatory compliance.
The capacity challenge
A conventional complaint service depends on trained personnel being available whenever calls arrive.
Demand is rarely constant. An organisation may need sufficient coverage for quiet periods, busy periods, evenings, weekends, and sudden increases in volume. A product recall or emerging safety concern can place immediate pressure on a team that was appropriately staffed for normal operations.
The cost extends beyond salaries. Personnel must understand the approved intake procedure, privacy requirements, escalation criteria, and documentation standards. Quality teams must then review records, identify omissions, and correct inaccurate or incomplete information.
The work also requires patience and concentration. Callers may be distressed, uncertain about product details, or unfamiliar with medical terminology. Important information such as model names, serial numbers, event descriptions, and patient outcomes must be captured accurately without making the interaction feel mechanical.
Relying on recruitment alone can create an inefficient balance. Insufficient coverage can cause queues, abandoned calls, and delayed review. Excess permanent capacity can leave trained personnel underused during quieter periods.
Relay is intended to provide another option by supporting the structured elements of complaint intake while directing situations that require judgement or personal assistance to qualified personnel.
What Pampero Relay is designed to do
Pampero Relay is being designed to guide callers through an approved complaint intake process and prepare structured information for qualified review.
The conversation follows requirements defined by the organisation. Relay is not intended to determine its own process or make unrestricted decisions about what should happen next.
The planned capabilities include:
- 1Clearly identifying the automated nature of the service
- 2Obtaining any acknowledgement or consent required by the organisation
- 3Establishing the purpose and context of the call
- 4Collecting and confirming relevant complaint information
- 5Recognising requests for human assistance and situations that require escalation
- 6Preparing a structured complaint record for qualified review
- 7Passing approved information into the organisation’s established complaint process
Relay is not intended to diagnose a patient, provide medical advice, investigate the complaint, or determine whether an event must be reported to a regulatory authority. These boundaries are deliberate.
How qualified personnel retain control
Human responsibility is central to the Relay operating model.
Authorised personnel are intended to oversee operations and intervene when a conversation requires judgement, reassurance, or specialist attention. Callers will also be able to request human assistance.
When a transfer occurs, the authorised person should receive the available context so that the conversation can continue without unnecessary repetition. The objective is to preserve continuity for the caller while giving the organisation full control over the interaction.
Relay is also intended to stop automated processing when it cannot continue within approved operating conditions. In those circumstances, the service should transfer responsibility to qualified personnel rather than continue with reduced safeguards.
Every completed automated intake will require human review. A named reviewer will compare the structured information with the original conversation, resolve uncertainty, make any necessary corrections, and approve the complaint record through the organisation’s controlled process.
Relay will not make the final Medical Device Reporting determination. That responsibility will remain with qualified personnel operating under the manufacturer’s approved procedures.
Integration with existing operations
Relay is being designed to work with the communication, identity, complaint management, and quality systems already used by an organisation.
The objective is to prevent the creation of an isolated artificial intelligence channel that personnel must manage separately. Approved information should enter the established operational environment, where authorised personnel can review it and continue the complaint process.
Access will be limited to what Relay requires for its approved function. The system will not independently search unrestricted patient, clinical, or company records.
Relay is also intended to preserve a reviewable history of each complaint journey. Depending on the approved implementation, this may include:
- 1The original conversation
- 2The information collected from the caller
- 3Relevant system events
- 4Human interventions
- 5Corrections and subsequent changes
- 6Final review and approval
Where electronic records are maintained to satisfy applicable FDA requirements and are relied upon for regulated activities, the organisation must determine how 21 CFR Part 11 applies.
Current development status
Relay is currently in architecture and validation planning.
The intended operating principles, human responsibilities, integration boundaries, and safety controls have been defined in an internal system architecture draft. Implementation decisions must be confirmed with each client’s quality, legal, privacy, information security, and operational teams.
These decisions include:
- 1The approved complaint intake procedure
- 2Human coverage and escalation responsibilities
- 3Consent and privacy requirements
- 4Supported languages and accessibility needs
- 5Record retention requirements
- 6Identity verification requirements
- 7Expected call volumes and service availability
- 8The point at which applicable regulatory timelines begin
Pampero does not claim that Relay is currently deployed, validated, certified, or approved for live complaint handling.
How performance will be measured
Following a validated deployment, Relay should be evaluated through operational, quality, and safety outcomes rather than simply by the number of calls it processes.
The proposed measures fall into six categories:
- 1Service accessibility: waiting times, abandoned calls, service availability, and performance during increased demand
- 2Intake completeness: the presence and accuracy of required complaint information
- 3Escalation performance: the correct identification of urgent situations, requests for assistance, and cases requiring qualified personnel
- 4Review efficiency: the time between initial contact, qualified review, correction, and final approval
- 5Record integrity: the completeness of the review history, system events, interventions, corrections, and approvals
- 6Experience and consistency: caller experience, staff experience, accessibility outcomes, and performance across supported languages and caller groups
These measures will help determine whether Relay reduces administrative pressure without weakening safety, quality, or accountability.
Discuss your complaint intake operation
Medical device organisations need complaint services that remain consistent when demand changes and every record may carry safety or regulatory significance.
Pampero Relay is being developed for operations where automation must remain controlled, reviewable, and accountable to qualified people.
A confidential initial discussion does not require access to patient information, proprietary systems, or sensitive technical infrastructure. It begins with the operation: what callers need, where capacity pressure occurs, which decisions require professional judgement, and what evidence the organisation must retain.
Pampero can then assess whether Relay is appropriate for the intended operation and identify what must be demonstrated before responsible deployment.
References
Sources and regulatory references
- 1Electronic Code of Federal Regulations (2026). Title 21, Part 11: Electronic Records and Electronic Signatures.→
- 2Food and Drug Administration (2003). Part 11, Electronic Records; Electronic Signatures: Scope and Application.→
- 3Food and Drug Administration (2016). Medical Device Reporting for Manufacturers.→
- 4Food and Drug Administration (2026). Medical Device Reporting: How to Report Medical Device Problems.→
- 5Food and Drug Administration (2026). Quality Management System Regulation.→
- 6Food and Drug Administration (2026). Quality Management System Regulation Frequently Asked Questions.→
Discuss a Project
Discuss your complaint intake operation
A confidential initial discussion does not require access to patient information, proprietary systems, or sensitive technical infrastructure. It begins with the operation: what callers need, where capacity pressure occurs, which decisions require professional judgement, and what evidence the organisation must retain.