Quality

FDA QMSR and ISO 13485 Quality System Consulting

Viltis provides experienced quality professionals to help medical-device organizations establish, assess, and remediate quality systems aligned with FDA QMSR and ISO 13485 requirements. We support imp…

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Practice areaQuality
Typical needCapability support for regulated programs
EngagementConsulting, augmentation, or hybrid
Related pathQuality

The client situation

When organizations typically need this capability.
  • Preparing for QMSR or ISO 13485 audit expectations
  • Building or modernizing a quality management system
  • Addressing CAPA, complaint, or document-control gaps
  • Integrating quality systems after M&A activity
  • Preparing for certification-body or FDA inspections

How Viltis helps

Structured support, end to end

  1. 01

    Step 1

    Gap assessments against ISO 13485 and QMSR expectations

  2. 02

    Step 2

    QMS implementation and SOP development

  3. 03

    Step 3

    Internal audits and management review support

  4. 04

    Step 4

    CAPA and complaint system remediation

  5. 05

    Step 5

    Supplier quality and change control strengthening

Viltis provides experienced quality professionals to help medical-device organizations establish, assess, and remediate quality systems aligned with FDA QMSR and ISO 13485 requirements. We support implementation and readiness - Viltis does not issue ISO certificates or act as a Notified Body.

Whether you are preparing for QMSR expectations incorporating ISO 13485:2016 principles, building a new QMS, integrating acquired product lines, or remediating audit findings, our consultants embed with your team to close gaps and sustain compliant operations.

Typical deliverables

What engagement can produce

Gap assessment report with prioritized risks

Remediation roadmap and ownership plan

SOP and work instruction packages

Internal audit reports

CAPA plans and effectiveness check models

Inspection-readiness binders and SME briefing packs

FAQ

Common questions

Can Viltis help us become ISO 13485 certified?

Yes - we help you prepare systems, records, and teams for certification-body audits. We do not issue the certificate itself.

How does FDA QMSR relate to ISO 13485?

FDA’s QMSR aligns medical-device quality requirements more closely with ISO 13485. Viltis helps organizations interpret and implement those expectations in practical QMS design.

Related proof

Biologics CMC PIP

CMC and quality oversight for a Phase III monoclonal antibody program at a CMO.

Read the case study →

Viltis provides consulting and resourcing for compliance readiness and operational support. We do not issue certifications or act as an accredited certification body.

Need support with FDA QMSR and ISO 13485 Quality System Consulting?

Discuss this requirement with our team - scope, timeline, and delivery model.

Schedule a consultationContact us