— Medical Device & IVD Auditing Services
Global Precision & Regulatory Assurance for Life Saving Technologies
In the medical device and in vitro diagnostic (IVD) sectors, quality is non negotiable—patient safety and product performance depend on it. As global regulatory systems continue to evolve through frameworks such as MDSAP, EU MDR, and IVDR, manufacturers face growing expectations, deeper scrutiny, and an increased need for robust Quality Management Systems (QMS).
Arirex delivers world class auditing expertise designed to help manufacturers navigate these challenges confidently. Our auditors evaluate your design controls, manufacturing processes, technical documentation, and post market systems with the precision expected by FDA, Health Canada, TGA, PMDA, ANVISA, and European Notified Bodies.
With Arirex, compliance is not just achieved—it is strengthened, sustained, and future ready.
Core Technical Areas
ISO 13485:2016 QMS Auditing
- Comprehensive QMS assessments including gap audits, full certification readiness reviews, process verification, and documentation evaluation.
- Inline references: ISO 13485:2016, ISO 9001:2015.
MDSAP — Medical Device Single Audit Program
A single, integrated audit covering regulatory requirements for:
- FDA 21 CFR 820
- Health Canada SOR/98 282
- Australia TGA
- Japan MHLW/PMDA
- Brazil ANVISA
Our approach reduces audit fatigue and increases transparency, while aligning your systems with global expectations.
Inline references: MDSAP Audit Model Companion Document.
EU MDR (2017/745) & IVDR (2017/746)
- Robust evaluation of all required technical documentation, including:
- Technical Files / Design Dossiers
- Risk Management Files
- PMS, PMCF, PSUR
- Clinical Evaluation Reports & Performance Evaluation Reports
Our MDR/IVDR specialists ensure your documentation withstands Notified Body review under the strengthened EU regulatory landscape.
Inline references: MDR Annex II/III, IVDR Annex II/III.
Risk Management & Design Control Auditing
- Assessment of product lifecycle integration, design verification/validation, and risk traceability from concept to post market.
- Inline references: ISO 14971:2019, FDA Design Control (21 CFR 820.30).
Software Validation & Cybersecurity Auditing
- Evaluation of software lifecycle documentation, validation evidence, cybersecurity controls, and development processes for software driven and digital health devices.
- Inline references: FDA Software Validation Guidance, IEC 62304.
Audit Deliverables
Every audit engagement includes structured, actionable outputs such as:
- Full device lifecycle audit report
- Supplier / subcontractor qualification and verification
- Gap analysis with direct regulatory citations
- PMS, vigilance, and UDI system assessments
- Technical documentation review & remediation roadmap
All deliverables are designed for implementation clarity and regulatory inspection readiness.
Regulatory References
Arirex auditing frameworks align with globally recognized standards, including:
- ISO 13485:2016
- ISO 14971:2019
- MDSAP Audit Model
- FDA: 21 CFR 820, 21 CFR 11
- EU MDR 2017/745 & IVDR 2017/746
- IEC 62304
- Health Canada, TGA, PMDA, ANVISA regulations