QMSAdvisor

Certification and Market Access

EU MDR and IVDR Readiness

Under the EU MDR and IVDR, a notified body audits both your quality management system and the technical documentation behind your devices, and it can arrive unannounced. We help you build the QMS processes and documentation those audits expect, and keep them current between visits.

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What You Receive

  1. 01QMS Gap Findings for MDR or IVDR
  2. 02Technical Documentation Review
  3. 03PMS and Vigilance Procedure Set
  4. 04Unannounced Audit Playbook
  5. 05Readiness Review Report

Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.

What It Is

The EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746 require notified body involvement for most devices outside the lowest risk class, depending on classification. The notified body runs conformity assessment audits, surveillance audits and unannounced audits, and the regulations require unannounced audits at least once every five years. Technical documentation is assessed alongside the QMS, and the two have to tell the same story.

The regulations ask for more than ISO 13485 alone. Technical documentation has to show conformity with the general safety and performance requirements, usually through a GSPR checklist that points to the evidence for each one. Clinical evaluation under the MDR, or performance evaluation under the IVDR, has to be planned, kept current and linked to post-market data. Post-market surveillance runs as a planned system, with post-market clinical follow-up (PMCF) under the MDR and post-market performance follow-up (PMPF) under the IVDR feeding back into risk management and evaluation.

Several roles and systems are specific to the EU. Manufacturers need a person responsible for regulatory compliance (PRRC). Vigilance covers serious incidents and field safety corrective actions. UDI assignment and registration in the EU's device database have to be built into labeling and release. Manufacturers outside the EU also work through an authorized representative. Each of these is a place where an unannounced audit can find a procedure that exists on paper but not in practice.

When You Need It

  • You're preparing for an initial conformity assessment with a notified body under the MDR or IVDR
  • Your device held a certificate under the earlier EU directives and its technical documentation hasn't been rebuilt to the regulation
  • A notified body audit or technical documentation assessment raised nonconformities you need to close
  • You need to be ready for an unannounced audit at your site or at a critical supplier
  • Your PMS, PMCF or PMPF plans exist, but the reports and data don't feed back into risk management
  • You're a US manufacturer adding the EU market to a QMS built for FDA

What We Do

  1. 01

    Confirm Devices and Conformity Routes

    With your regulatory lead, we confirm which devices, classes and conformity assessment routes are in scope, because they decide what the notified body will audit and sample.

  2. 02

    Assess the QMS Against the Regulation

    An AI-assisted first pass checks your procedures against ISO 13485:2016 and the regulation's QMS expectations, and an advisor reviews every result. Gaps often sit in PMS, vigilance, PRRC responsibilities and UDI.

  3. 03

    Review Technical Documentation Structure

    We check that the GSPR checklist points to real, current evidence, that clinical or performance evaluation links to risk management and post-market data, and that the documentation matches the device as it's actually built.

  4. 04

    Strengthen Post-Market and Vigilance Processes

    We help you write or tighten the PMS plan, the PMCF or PMPF plan, reporting and vigilance procedures, and connect their outputs to CAPA, risk management and evaluation updates.

  5. 05

    Prepare for Announced and Unannounced Audits

    We run a readiness review the way a notified body auditor would, including tracing a recent production lot and a complaint through the system, and brief staff on how an unannounced visit unfolds.

  6. 06

    Support Nonconformity Closure

    When findings arrive, we help you write corrections and corrective actions backed by evidence the notified body can verify.

Deliverables

  • QMS Gap Findings for MDR or IVDR

    Advisor-reviewed findings against ISO 13485:2016 and the regulation's QMS requirements, with sources, severity and owners.

  • Technical Documentation Review

    Notes on structure, GSPR traceability and evidence gaps across the documentation you supply.

  • PMS and Vigilance Procedure Set

    Updated procedures and plan templates for PMS, PMCF or PMPF and vigilance, sized to your devices.

  • Unannounced Audit Playbook

    Who receives the auditors, who retrieves documents, how a sample device is pulled, and who speaks for each process.

  • Readiness Review Report

    Readiness by process and by device file, with open items, owners and due dates.

How the Platform Helps

  • Technical Documentation in One Library

    Upload design, risk, clinical and labeling files in their original formats. Each file carries a SHA-256 fingerprint, so you can show which version was reviewed.

  • Findings With Document and Location

    Every advisor-reviewed finding cites where it came from, so a gap in a GSPR row leads straight to the file behind it.

  • Evidence Accepted or Returned With Notes

    Your team submits evidence, an advisor accepts it or requests a revision, and every resubmission states what changed.

  • Activity History for Every Decision

    An immutable record of who submitted, reviewed and accepted each item, useful when a notified body asks how a gap was closed.

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Audits and Inspections It Prepares You For

Standards and Regulations in Scope

Questions About This Service

How often do notified bodies conduct unannounced audits?

The MDR and IVDR require unannounced audits at least once every five years, and a notified body can schedule them more often based on risk. They can include checking a recently produced device against the technical documentation. Your system has to be audit-ready on any working day, not only around planned surveillance dates.

Is ISO 13485 enough for the MDR or IVDR?

ISO 13485:2016 is the usual foundation for the QMS, but the regulations add requirements beyond it, such as the PRRC, PMS and post-market follow-up plans, vigilance, UDI and the content of technical documentation. A QMS built only to the standard will usually have gaps against the regulation.

What is a GSPR checklist?

It's a working document that lists each general safety and performance requirement, says whether it applies to your device, and points to the evidence of conformity. Auditors use it to navigate your technical documentation, so a checklist pointing to outdated or missing evidence quickly turns into findings.

Do you write clinical or performance evaluation reports?

Our focus is the quality system and the evidence behind it. We review whether clinical or performance evaluation is planned, current and connected to risk management and post-market data. Any authoring scope is agreed case by case after an assessment call.

Can you help a US manufacturer enter the EU?

Yes, on the QMS side. Under the QMSR a US system already rests on ISO 13485:2016, so the work is mostly adding EU-specific processes and building technical documentation to the regulation. Classification, conformity route and authorized representative arrangements are regulatory decisions we scope with you case by case.

Request an Assessment

Discuss EU MDR and IVDR Readiness With an Advisor

Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.

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