ABOUT CARELYFT QUALITY SERVICES
CareLyft delivering specialised medical device quality management services to manufacturers worldwide. We integrate regulatory intelligence, process automation, and domain expertise to help clients build robust quality systems, maintain compliance, and bring safe, effective devices to market — faster and more reliably.
CareLyft's Quality Services cover six core pillars of medical device quality management, each delivered by dedicated specialists with hands-on regulatory and manufacturing experience. Our services are scalable to organisations of any size — from early-stage startups to established global manufacturers.
01. CAPA Management
End-to-end Corrective and Preventive Action management to identify, investigate, resolve, and prevent quality issues — fully aligned with ISO 13485, 21 CFR Part 820, and MDR requirements.
- Root cause analysis (RCA) using structured methodologies
- CAPA initiation, investigation, action planning, implementation, and effectiveness verification
- Complaint-triggered and audit-triggered CAPA workflows
- CAPA trending, KPI dashboards, and periodic management review reporting
- Training and coaching of in-house quality teams on CAPA best practices
02. Compliance & Desktop Audit Support
Comprehensive audit readiness and remote/desktop audit support to prepare organisations for notified body inspections, regulatory authority audits, and client-driven quality assessments.
- Gap assessments against ISO 13485, EU MDR/IVDR, 21 CFR Part 820, and applicable standards
- Desktop (off-site) audit support — technical file review, QMS documentation analysis
- Internal audit programme design, execution, and reporting
- Preparation for Notified Body audits, FDA inspections, and MDSAP audits
- Mock audit simulations with detailed finding reports and remediation plans
- Regulatory intelligence updates and proactive compliance horizon-scanning
03. Supplier Evaluation
Systematic supplier qualification, monitoring, and performance management programmes to ensure your supply chain meets quality and regulatory expectations — and stays that way.
- Supplier risk classification and qualification criteria development
- Initial supplier qualification audits (on-site and remote/desktop)
- Supplier questionnaire design, evaluation, and scoring frameworks
- Approved Supplier List (ASL) maintenance and periodic re-qualification
- Supplier audit report generation, CAPA follow-up, and improvement tracking
- Critical supplier performance monitoring and escalation management
04. MDSAP Support
Dedicated support for Medical Device Single Audit Programme (MDSAP) readiness, execution, and post-audit remediation — enabling simultaneous market access across participating regulatory authorities.
- MDSAP gap analysis against the seven audit model chapters (Management, Measurement, Design, Purchasing, Production, Supporting Processes, Distribution)
- MDSAP readiness assessment and remediation roadmap development
- QMS alignment to MDSAP audit model requirements (FDA, Health Canada, ANVISA, TGA, MHLW/PMDA)
- Documentation preparation: audit triage, objective evidence compilation
- On-site / remote audit support and real-time query response
- Post-audit non-conformance management and close-out support
05. Document Management
Structured creation, review, approval, and control of quality system documentation to maintain a compliant, inspection-ready document management system at all times.
- QMS documentation design: SOPs, Work Instructions, Forms, Templates, and Policies
- Document lifecycle management — creation, version control, approval, and retirement
- Electronic Document Management System (EDMS/eQMS) setup and administration
- Legacy document review, remediation, and migration to compliant formats
- Controlled document training and change notification workflows
- Technical file and Design History File (DHF/DMR/DHR) documentation support
06. Manufacturing Quality Support
On-the-ground and remote quality engineering support to help manufacturing sites establish, maintain, and continuously improve production quality systems and processes.
- Process validation support: IQ, OQ, PQ — protocol design, execution, and reporting
- Statistical Process Control (SPC) implementation and monitoring
- Non-conforming product management and disposition support
- Manufacturing process FMEA (pFMEA) and risk assessment
- Cleanroom and environmental monitoring programme support
- Quality engineering resource augmentation for production floor quality activities
WHY CHOOSE CARELYFT
Global reach — 40+ markets, region-specific expertise
Broad device portfolio coverage: SaMD, IVD, wearables, drug-device combos
Transparent, milestone-driven project management
Scalable engagement models for startups to large manufacturers
Seamless integration with client QMS platforms and workflows
Cost-efficient offshore and hybrid delivery models
DEVICE TYPES SUPPORTED
CareLyft's PMS Services support the full spectrum of medical device categories: