ABOUT CARELYFT PMS SERVICES
CareLyft's Post-Market Surveillance (PMS) Services provide medical device manufacturers with a structured, end-to-end capability to monitor, evaluate, and act on real-world device performance data. With deep regulatory expertise across 40+ markets, CareLyft ensures your devices remain safe, effective, and compliant — from first commercialisation through their entire operational lifetime.
Our PMS team combines experienced regulatory affairs professionals, clinical specialists, and complaint management experts to deliver a seamless, audit-ready surveillance programme — fully aligned with EU MDR 2017/745, EU IVDR 2017/746, 21 CFR Part 803/806, ISO 13485, and applicable global vigilance frameworks.
CareLyft's PMS programme is built on eight integrated service pillars, each designed to address a critical dimension of post-market oversight. Our services can be engaged individually or as a fully managed, end-to- end PMS programme tailored to your device portfolio and regulatory obligations.
01. Complaints Intake, Evaluation, Investigation & Closure
A fully managed complaint handling programme covering the complete complaint lifecycle — from first receipt through thorough investigation to formal closure — in compliance with ISO 13485 Clause 8.2.2, 21 CFR Part 820.198, and MDR Article 87 requirements.
- Multi-channel complaint intake: phone, email, field service reports, and eQMS portals
- Initial triage and reportability assessment — MDR / MDV / voluntary report determination
- Technical and clinical complaint investigation, including device analysis coordination
- Root cause analysis (RCA) and risk-benefit evaluation for complaint events
- Regulatory reporting decision documentation and justification records
- Complaint trending, signal detection, and escalation to CAPA where required
- Complaint closure with comprehensive investigation summary reports
02. Vigilance Reporting
End-to-end incident reporting across global markets — timely, accurate, and fully compliant submissions to competent authorities.
- SI & FSCA reporting under EU MDR/IVDR
- FDA MDR submissions (21 CFR Part 803)
- Health Canada MPR & TGA/PMDA adverse event reporting
- Competent Authority query management & supplemental submissions
- Vigilance report authoring, submission & tracking
- PSUR & SSCP preparation and support
03. UDI & Device (Tracking) Traceability Management
Robust tracking systems maintaining product traceability across the supply chain and end-use environment — aligned with UDI and post-market requirements.
- Unique Device Identification (UDI) system setup and compliance — EU EUDAMED, FDA GUDID, and global databases
- Lot/batch and serial number traceability across distribution tiers
- Implant & high-risk device tracking programme management
- Device registry enrolment & ongoing maintenance
- Track & trace protocols for mandatory tracking obligations
- Distribution record review & field inventory reconciliation
04. Medical & Technical Inquiry Management
Structured handling of inquiries from HCPs, patients, and distributors — accurate, compliant responses that support safe device use.
- Inquiry intake, logging, and classifications
- Clinical & technical response authoring by qualified professionals
- Review & approval workflows aligned with regulatory standards
- Off-label use inquiry management & documentation
- Trending analysis to identify recurring safety or usability signals
- Response library & medical information database maintenance
- Escalation pathways for adverse events or safety concern
05. Device Recall and Return Management
End-to-end support for device recalls, removals, and market withdrawals — swift, compliant action to protect patient safety and regulatory standing.
- Recall classification & regulatory notification preparation (Class I/II/III, FSN)
- Recall strategy development & effectiveness check (REC) design
- Customer & distributor notification authoring and dispatch
- Returned device logging & disposition coordination
- Regulatory agency correspondence & progress reporting
- Post-recall documentation & closure submissions
- Mock recall readiness exercises & procedure development
06. PMS Reporting (PMSR, PSUR, PMCF)
- Post-Market Surveillance Reports (PMSR)
- Periodic Safety Update Reports (PSUR)
- Post-Market Clinical Follow-up (PMCF) reports
- Benefit-risk evaluation and clinical data analysis
- Regulatory-compliant documentation
07. Post Market / Device Technical Support
Specialised support bridging field performance, complaint investigations, and regulatory documentation — backed by deep device knowledge.
- Failure analysis & returned device evaluation
- Post-market change impact reviews (design & labelling)
- CER, PMCF, and PMPF updates
- Usability/human factors post-market studies
- SaMD software & cybersecurity assessments
- Regulatory technical file updates from post-market findings
- Expert technical review for product liability
08. Health Hazard Evaluation
Rigorous, structured Health Hazard Evaluation (HHE) to assess the clinical impact of device defects, failures, or non-conformities — providing the evidentiary basis for informed reportability and recall decisions.
- HHE initiation triggered by complaints, audit findings, CAPA, or vigilance events
- Clinical risk assessment using ISO 14971 risk management principles
- Reportability determination: serious injury, death, or malfunction assessment
- HHE documentation to regulatory submission standard (FDA, MDR, Health Canada)
- Medical and clinical expert review and sign-off coordination
- HHE outcomes fed back into risk management files and PMS plans
REGULATORY FRAMEWORKS SUPPORTED
CareLyft's PMS team operates across the following regulatory frameworks and standards:
| EU MDR 2017/745 | EU IVDR 2017/746 | ISO 13485:2016 |
| 21 CFR Part 803 (FDA MDR) | 21 CFR Part 806 (Recalls) | 21 CFR Part 820 (QSR) |
| ISO 14971:2019 | MEDDEV 2.12/1 Rev 8 | Health Canada MDR |
| TGA (Australia) | MHLW / PMDA (Japan) | MDSAP |
WHY CHOOSE CARELYFT FOR PMS
ISO 13485-certified PMS operations with End-to-End PMS lifecycle management
Experienced Regulatory professionals with strong regulatory expertise and domain knowledge
Audit-ready documentation and traceability at every step
Seamless eQMS and complaint system integration
Scalable solutions tailored to your business needs
Multi-market simultaneous vigilance submissions
Scalable — from single-product to full portfolio management
Timely submissions and audit-ready processes
Transparent KPI reporting and real-time dashboards
High-quality, compliant documentation and reporting
DEVICE TYPES SUPPORTED
CareLyft's PMS Services support the full spectrum of medical device categories: