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IEC 62304:2006 + AMD1:2015 - Gap Analysis
IEC 62304:2006 + AMD1:2015 - Internal Audit
AI TPLC - Gap Analysis
Non-Product Software (NPS) Validation
HIPAA & GDPR Compliance Package
ISO 13485:2016 - Internal Audit
ISO 13485:2016 -
Gap Analysis
MDSAP - Internal Audit
FDA QMSR –
Internal Audit
EU MDR - Internal Audit
IVDR - Internal Audit
Quality Agreement
Supplier Audit
Ready to take the next step?
Get a QuoteIEC 62304:2006 + AMD1:2015 –
Gap Analysis
Led by a Senior Software Compliance Auditor (20+ years of experience).
Remote assessment.
Turnaround time: 1 day.
IEC 62304:2006 + AMD1:2015 – Internal Audit
Led by a Senior Software Auditor (20+ years of experience).
Remote assessment, aligned with FDA and EU MDR auditor expectations. Audit scope includes linkage with the QMS.
Turnaround time: 2 days.
AI TPLC – Gap Analysis
Led by a Senior AI Software Q&R Auditor (20+ years of experience). Meets FDA, EU MDR, and AI Act expectations.
Scope includes AI lifecycle governance, model change control, data management, and alignment of AI controls with the overall QMS and Risk Management.
Turnaround time: 1 day.
Non-Product Software (NPS) Validation
Led by a Senior Software QA Validation Engineer (20+ years of experience).
Efficient and compliant with ISO 13485, MDSAP, FDA, and EU MDR.
Turnaround time: 1-2 weeks.
HIPAA & GDPR Compliance Package
Customized policy and SOPs tailored to fit your organization.
FDA and MDR compliant.
Turnaround time: 1-2 weeks.
ISO 13485:2016 – Internal Audit
Led by a Certified Senior Lead Auditor (15+ years of experience, over 100 audits performed).
Desktop audit. Focus on compliance with ISO 13485 requirements.
Turnaround time: 2 days.
ISO 13485:2016 –
Gap Analysis
Led by a Certified Lead ISO 13485 Auditor (25+ years of experience, over 150 NB audits performed).
Systematic. Prioritized report delivered.
Turnaround time: 1-2 days.
MDSAP – Internal Audit
Led by an MDSAP Expert (15+ years of experience and over 10 MDSAP certifications).
Multi-jurisdiction. MDSAP task-based Audit Model.
Turnaround time: 2 days.
FDA QMSR –
Internal Audit
Led by an FDA Compliance Auditor (15+ years of experience and over 10 FDA inspections).
Desktop audit. Focus on inspection-trigger risks and FDA’s new inspection techniques under QMSR.
Turnaround time: 2 days.
EU MDR - Internal Audit
Led by a Certified MDR Internal Auditor (15+ years of experience and over 10 MDR audits).
Desktop audit.
Turnaround time: 2 days.
IVDR - Internal Audit
Led by a Certified IVDR Internal Auditor (15+ years of experience and multiple IVDR audits).
Desktop audit. Assessment of performance evaluation and PMPF structure.
Turnaround time: 2 days.
Quality Agreement
Led by a Supplier QA Expert (15+ years of experience).
Desktop audit featuring one consolidated expert-led online session involving supplier and client. Risk-based approach. FDA-, EU MDR-, and MDSAP-compliant.
Turnaround time: 1 day.
Supplier Audit
Led by a Supplier QA Expert (15+ years of experience).
Desktop audit aligned with FDA, Notified Body, and MDSAP audits. Featuring one consolidated tri-party expert session online.
Turnaround time: 1 day.
