Accelerating global medical device compliance with expert-led, AI-powered solutions.
Navigate complex regulatory requirements with integrated regulatory, quality, clinical and post-market expertise. From strategy to market authorisation and lifecycle compliance, MedoQi combines specialist knowledge with intelligent technology to deliver efficient, evidence-based solutions.
- II · 1Device description & specificationVariants, accessories, Basic UDI-DI, classification rationale
- II · 2Information supplied by the manufacturerLabels and instructions for use, in each required language
- II · 3Design & manufacturing informationDesign stages, manufacturing sites, critical suppliers
- II · 4General safety & performance requirementsAnnex I checklist mapped to standards and evidence
- II · 5Benefit–risk analysis & risk managementISO 14971 risk management file and report
- II · 6Product verification & validationPre-clinical data and clinical evaluation report (CER)
- IIIPost-market surveillancePMS plan, PMCF plan and PSUR
Specialists for your file, your QMS and your submissions
Regulatory, quality, clinical and post-market experts who plan, author, remediate and defend your documentation through review.
Explore consulting services → AI-powered solutionsPurpose-built regulatory AI, reviewed by experts
GapSmart AI, WriteCortex AI and IntelliVigilance AI for gap assessment, controlled authoring and post-market compliance.
Explore AI solutions →The problems manufacturers bring to us
Each one has a cost in time, budget or market access. Each has a defined route through it.
Global market access complexity
Different classifications, submission pathways and national requirements for every market you enter.
Explore solutions → DocumentationRegulatory documentation burden
Technical documentation, clinical and performance evidence, and remediation competing for the same internal team.
Explore solutions → Quality systemsQuality system transformation
FDA QMSR, ISO 13485, MDSAP and audits, with records that now face closer inspection.
Explore solutions → EvidenceClinical evidence gaps
Clinical evaluation, performance evidence, literature appraisal and post-market studies that must hold up at review.
Explore solutions → Post-marketPost-market compliance
Complaint handling, vigilance, trend reporting and PMS governance across several jurisdictions at once.
Explore solutions → Digital transformationAI and digital regulatory work
Adopting AI in regulatory workflows in a way that stays controlled, reviewable and defensible.
Explore solutions →Expertise across the regulatory lifecycle
Engage one practice for a defined deliverable, or all four as an integrated team working from a single plan.
Navigate global regulatory pathways and achieve market authorisation
Typical challenge. Unclear classification, a pathway chosen too late, or a file that will not survive review.
What we deliver- Classification and pathway strategy across the EU, US and 75+ markets
- Technical documentation and submission dossiers
- Pre-submission meetings, review management and query responses
Build audit-ready, scalable quality systems
Typical challenge. A QMS built for one market or one audit, now facing QMSR, MDSAP or IVDR expectations.
What we deliver- ISO 13485 implementation and certification support
- FDA QMSR readiness and MDSAP alignment
- Mock audits, inspection support and CAPA effectiveness
Generate defensible clinical and performance evidence
Typical challenge. Evidence that is thin, outdated or not traceable to the claims being made.
What we deliver- Clinical evaluation (MDR Annex XIV) and performance evaluation (IVDR Annex XIII), scoped to the device's risk and route
- Literature reviews with documented search, appraisal and traceability
- PMCF and PMPF planning and studies
Maintain compliance through proactive lifecycle surveillance
Typical challenge. Complaints handled case by case, late reports, and trends spotted after they matter.
What we deliver- PMS plans, PMSR and PSUR
- Managed complaint handling and vigilance reporting
- Trending that feeds the risk file and clinical evaluation
Assess, validate, remediate, submit, maintain
One model across every service and market. AI speeds up the first pass; specialists decide what goes into your file.
- 01
Assess
AI-assisted initial assessment of your file, QMS or portfolio against the applicable requirements.
GapSmart AI - 02
Validate
Expert delta review. Specialists confirm, correct and prioritise every finding.
Specialist review - 03
Remediate
Controlled documentation, authored and updated under document control with evidence references.
WriteCortex AI - 04
Submit
Regulatory support: dossier compilation, submission and review-cycle management.
Regulatory team - 05
Maintain
Lifecycle compliance: PMS, vigilance, changes and renewals.
IntelliVigilance AI
AI involvement varies by project scope, tool readiness and the level of human review required.
Experienced on the manufacturer's side of every review
Our specialists have prepared technical documentation for, and managed review rounds with, Notified Bodies designated under the EU MDR and IVDR, and regulators including the US FDA. We know how reviewers read a file, which questions follow which gaps, and how to answer them with evidence.
Names describe our specialists' review experience. They do not imply endorsement by, or affiliation with, these organisations.
MedoQi acts only on the manufacturer's side. Notified Bodies are independent conformity assessment bodies: certification decisions rest solely with them, and no consultancy can influence that outcome.
We shortlist Notified Bodies whose NANDO designation covers your device codes and conformity route, then support the application and contract.
Single-point liaison, query tracking, evidence compilation and response drafting, with SME review before anything is sent.
Mock QMS and technical documentation audits that follow Notified Body methods, so your team is ready for the real one.
Change notifications, surveillance and unannounced audit readiness, and recertification planning.
Market-entry strategy for every region you target
Country-specific pathways, documentation, quality requirements and post-market obligations, with dedicated guidance for each priority market.
North America
Middle East & Africa
- Saudi Arabia On request
- United Arab Emirates On request
- Egypt On request
- South Africa On request
One AI ecosystem, built around expert review
Three products, each mapped to a stage of our delivery model, and each designed so a qualified specialist confirms the output before it reaches your file.
AI-assisted gap assessment with clause traceability, severity ranking and specialist validation.
GapSmart AI → Remediate · Testing and validationControlled regulatory authoring with evidence-linked drafts, defined document structures and review steps.
WriteCortex AI → Maintain · Pilot phaseComplaint intake, IMDRF coding, reportability support and trend monitoring, with human-reviewed decisions.
IntelliVigilance AI →Built for device and diagnostics manufacturers
Class I to Class III
Non-invasive, active, implantable and reusable surgical devices, including drug-device combination products.
Medical devices → In vitro diagnosticsClass A to Class D
Assays, reagents, controls, calibrators, instruments and software, including companion diagnostics.
In vitro diagnostics → Startups & scale-upsMedTech Startup Accelerator
A fractional RA/QA team and lean ISO 13485 systems, structured in stages from first classification to submission.
Startup Accelerator → India · going globalIndian manufacturers scaling up
CDSCO licences for higher-risk devices, a QMS that meets the Medical Devices Rules and ISO 13485, and evidence for CE marking and FDA clearance.
India market page → Japan · going globalJapanese manufacturers entering the US and EU
AI-assisted gap assessment, expert delta review, remediation and submission support from a team that knows both systems.
Japan-to-global → SaMD · AISoftware and AI developers
Qualification and classification, IEC 62304, cybersecurity, PCCPs and clinical evaluation designed for software.
Digital health services →Work our specialists have delivered
19 anonymised case studies across regulatory, quality, clinical and post-market work, each setting out the challenge, what we did and the outcome.
Multi-geography CER programme
Dedicated writers and reviewers delivering submission-ready CERs for several markets.
Ophthalmic materials LSRs
An agreed literature roadmap and template that removed recurring delays.
Neurovascular portfolio support
CERs, CEPs, SSCPs and PMCF plans across EU, French, Chinese and US submissions.
Anonymised. Documents were prepared by our specialists; regulatory decisions remain with the authorities and Notified Bodies concerned.
Regulatory insight from our specialists
FDA QMSR in force: what inspectors can now see
Management review, internal audit and supplier audit records are now open to FDA inspection.
Read briefing → IVD · GuideHow SVR, APR and CPR come together in the PER
The three pillars of IVDR performance evidence, and the gaps reviewers find most often.
Read guide → Post-market · BriefingReportability: human decisions, AI assistance
Reporting clocks across the EU, US, Canada and Australia, and where AI can help.
Read briefing →Work with us the way your programme needs
Not sure which model fits? Tell us what you need and we will recommend one in the consultation.
| Engagement model | Best fit | Typical scope |
|---|---|---|
| Dedicated regulatory team | Ongoing documentation and QMS support | Named specialists working as an extension of your team |
| Fixed-scope project | A CER, PER, technical file or regulatory submission | Defined deliverables, milestones and acceptance criteria |
| Interim and specialist support | Short-term expertise or interim cover for a role | Reviews, audits, workshops or an interim RA, QA or PMS lead |
| Managed compliance service | Sustained QMS, PMS and vigilance operations | Outsourced or co-sourced operations with service levels |
| AI pilot or proof of concept | Evaluating MedoQi technology on a controlled use case | A time-boxed pilot with agreed success measures |
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.