ABOUT CARELYFT SUSTENANCE ENGINEERING SERVICES
Medical devices require sustained regulatory attention long after they reach the market. Evolving standards, updated guidance documents, new clinical evidence requirements, and changing risk frameworks can render previously approved technical documentation non-compliant — exposing manufacturers to audit findings, certification gaps, and market access risks.
CareLyft's Sustenance Engineering Services provide structured, expert-led remediation and lifecycle maintenance programmes for in-market medical devices. Our specialists work systematically across Design History Files (DHF), Risk Management Files (RMF), Clinical Evaluation Reports (CER), complaint data, PMS plans, and Quality Management Systems (QMS) — bringing legacy documentation up to current regulatory standards and keeping it there.
OUR SUSTENANCE ENGAGEMENT MODEL
Every CareLyft Sustenance engagement follows a structured five-phase model designed to systematically identify gaps, prioritise remediation activities, and deliver submission-ready outputs with full auditability.
| Legacy Review | Gap identification across DHF, RMF, CER, and QMS documentation against current regulatory standards |
| Remediation Plan | Prioritised roadmap with milestones, resource allocation, and regulatory submission timelines |
| Execution | Expert-led document creation, updating, and alignment across all technical file components |
| Verification | Independent review, cross-referencing, and completeness checks prior to submission or audit |
| Submission Support | Regulatory submission preparation, query response, and post-submission maintenance |
SCOPE OF SUSTENANCE ENGINEERING SERVICES
CareLyft's Sustenance Engineering programme is organised across six core service areas, each targeting a critical component of the medical device technical and quality file. Services can be engaged individually for targeted remediation or as a fully integrated programme covering the entire documentation landscape.
01. Design History File (DHF) Remediation
Comprehensive review, gap analysis, and remediation of Design History Files to meet current regulatory expectations under EU MDR 2017/745, 21 CFR Part 820 Subpart C, and ISO 13485 Clause 7.3 — ensuring your technical documentation is audit-ready and certification-compliant.
02. Risk Management File (RMF) Remediation
Structured remediation of Risk Management Files to full alignment with ISO 14971:2019 — including risk analysis, risk evaluation, risk controls, residual risk assessment, and benefit-risk determination — ensuring defensible, current risk documentation for regulatory submissions and audits.
03. Clinical Evaluation Report (CER) Updates
Expert-authored Clinical Evaluation Report updates and full rewrites to maintain compliance with MEDDEV 2.7/1 Rev 4, EU MDR Article 61, and Annex XIV — incorporating current clinical evidence, post-market data, and state-of-the-art assessments.
04. Complaint Data Analysis
In-depth retrospective and ongoing analysis of complaint data to identify safety signals, support regulatory reporting decisions, and feed evidence back into risk management, clinical evaluation, and PMS documentation.
05. Post-Market Surveillance (PMS) Plan and Report
Authoring and periodic updating of PMS Plans and PMS Reports (PMSR) / Periodic Safety Update Reports (PSUR) to satisfy EU MDR Article 84–86, ISO 13485 Clause 8.2, and global post-market documentation obligations for in-market devices.
06. QMS Remediation
Targeted remediation of Quality Management System documentation and processes to close gaps identified against ISO 13485:2016, EU MDR Annex IX/XI, 21 CFR Part 820, and MDSAP audit model requirements — restoring audit readiness and regulatory confidence.
REGULATORY FRAMEWORKS & STANDARDS
CareLyft's Sustenance Engineering Services operate across the following regulatory frameworks:
| EU MDR 2017/745 | EU IVDR 2017/746 | ISO 13485:2016 |
| ISO 14971:2019 | IEC 62304 (Software) | IEC 62366-1 (Usability) |
| MEDDEV 2.7/1 Rev 4 | 21 CFR Part 820 | 21 CFR Part 803/806 |
| MDSAP Audit Model | Health Canada MDR | TGA / PMDA |
WHY CHOOSE CARELYFT FOR SUSTENANCE ENGINEERING
ISO 13485-certified operations underpinning all remediation work
Experience with legacy devices across all risk classes (Class I-III, IVD A-D)
Scalable engagement — single document to full technical file overhaul
Audit simulation and mock inspection support post-remediation
Cross-functional team: regulatory, clinical, quality, and engineering
Milestone-driven delivery with transparent progress tracking
Integrated approach linking DHF, RMF, CER, PMS, and QMS outputs
Cost-efficient offshore and hybrid resourcing models
DEVICE TYPES SUPPORTED
CareLyft's PMS Services support the full spectrum of medical device categories: