Quality Systems & Risk Management That Drive Regulatory Success
From ISO 13485 implementation and risk management to comprehensive audit preparation-our former Notified Body auditors deliver quality and compliance solutions that withstand the closest regulatory scrutiny for both IVDs and medical devices.
Quality Excellence for Medical Devices & IVDs
In today’s rigorous regulatory environment, robust quality systems and thorough risk management are non-negotiable for medical device and IVD manufacturers. MDx provides comprehensive quality, risk management, and audit services designed to secure and maintain compliance while optimizing your operational efficiency.
Our team-featuring former Notified Body auditors and quality experts from leading manufacturers-delivers practical, scalable solutions tailored to your specific technologies, organizational needs, and regulatory requirements. Whether you’re implementing ISO 13485 for the first time, transitioning to MDR/IVDR, or preparing for a high-stakes audit, MDx ensures your quality systems meet both regulatory demands and business objectives.
Core Quality, Risk & Audit Services
- Gap assessments against current requirements
- Full QMS development for startups and SMEs
- Implementation planning and execution
- Documentation development (quality manual, SOPs, work instructions)
- Management representative guidance and support
- Pre-certification audit preparation
- Notified Body and certification body selection
- MDSAP, EU MDR/IVDR, and FDA QSR alignment
- Process mapping and optimization
- Document control system implementation
- Quality records management solutions
- CAPA systems development and refinement
- IVD-specific quality controls and QMS adaptations
- QMS performance metrics and reporting
- Temporary quality leadership during transitions
- Remote QA support packages
- Virtual quality team solutions
- QA department setup for startups
- Training of quality personnel
- Management review support and facilitation
- Risk management planning
- Risk management file development
- Production and post-production risk monitoring
- Risk/benefit analysis documentation
- Hazard identification workshops
- Device-specific and IVD-specific risk management approaches
- Risk management plans
- Risk management reports
- Risk analysis using FTA, FMEA, HAZOP
- Process FMEA (pFMEA) development
- Design FMEA (dFMEA) creation
- Usability risk assessments (IEC 62366)
- Cybersecurity risk management (IEC 80001)
- IVD-specific risk management (e.g., false results, clinical impact)
- Integration with clinical evaluation/performance evaluation
- Alignment with usability engineering
- PMS/PMCF/PMPF risk data integration
- Software risk management (IEC 62304)
- Biocompatibility risk assessments
- Special process risk controls
- Risk-based approaches to QC and batch release for IVDs
- ISO 13485 compliance audits
- MDR/IVDR readiness assessments
- MDSAP internal audits
- Process audits
- Remote and hybrid audit execution
- Special process audits
- Software development audits
- Laboratory process audits (ISO 15189)
- Comprehensive audit reports with remediation plans
- Critical supplier qualification
- OEM audits
- International supplier assessment
- Remote supplier audit programs
- Supplier classification and monitoring systems
- Component supplier audits (for both devices and IVDs)
- Laboratory supplier audits
- Notified Body audit readiness
- FDA inspection preparation
- MDSAP audit planning
- Mock inspections and simulations
- Audit response management
- Audit finding remediation
- Competent Authority inspection support
Specialized Quality & Compliance Services
Medical Device & IVD Regulatory Requirements
Person Responsible for Regulatory Compliance (PRRC)
MDR/IVDR Quality Compliance
Validation & Verification
Design Verification & Validation
Process Validation
Computer System Validation
| Capability |
|---|
| Former Notified Body Auditors |
| Industry Experience |
| Combined Device & IVD Expertise |
| Practical Approach |
| Integrated Services |
| Mock Audit Experience |
| Technology-Specific Templates |
| Right-sized Solutions |
| MDx CRO | Typical Consultants |
|---|---|
 From BSI, TÜV SÜD |  Rarely available |
| Experts from top 10 IVD & device manufacturers | Often theoretical knowledge only |
| Specialists in both regulatory frameworks | Usually focused on one area |
| Business-focused compliance solutions | Compliance at expense of efficiency |
 Quality + Regulatory + Clinical |  Usually single specialty |
| Realistic NB/FDA scenarios | Generic assessments |
| For IVDs, devices, software | Generic templates |
| Tailored to company maturity & resources | One-size-fits-all approach |
Former BSI, TÜV SÜD auditors on staff
Zero major findings in our last 10 IVDR-specific quality system audits
End-to-end ISO 14971 risk management (RMF) delivered and aligned with Notified Body expectations
Our Quality & Risk Management Process
Comprehensive review of existing systems, documentation, and practices
Identification of compliance gaps against relevant standards and regulations
Development of prioritized implementation or remediation roadmap
Creation or revision of quality system documentation
Practical execution of quality processes and risk management
Internal audits and pre-certification assessments
Expert guidance through certification audits
Ongoing monitoring and optimization of quality systems
A precision medicine startup with limited resources needed to establish an ISO 13485-compliant QMS to support CE marking of their first advanced NGS diagnostic test under IVDR.
MDx implemented a staged QMS development approach, prioritizing key processes needed for immediate regulatory requirements while building a scalable framework for future growth.
ISO 13485 certification achieved within 6 months with zero major nonconformities, enabling the client to proceed with IVDR technical documentation submission on schedule.
A Class IIb medical device manufacturer received major nonconformities related to risk management during their MDR surveillance audit, threatening their certification status.
MDx conducted a comprehensive risk management file review, facilitated new risk analysis sessions, and implemented a revised ISO 14971:2019-compliant risk management process.
All nonconformities closed within the required timeframe, with MDx’s approach receiving positive feedback from the Notified Body for its thoroughness and compliance.
A global IVD manufacturer needed to achieve MDSAP certification to maintain market access in Canada, Brazil, Australia, and Japan, with a compressed 7-month timeline.
MDx deployed a team of QMS experts and former auditors to conduct a gap assessment, implement remediation, and conduct comprehensive mock audits across multiple sites.
Successful MDSAP certification with only minor findings, achieved on schedule and maintaining uninterrupted global market access.
Frequently Asked Questions
Ask us a Question- How does MDx approach QMS implementation differently from other consultants?
Our quality experts have both Notified Body and industry experience, allowing us to implement systems that are both compliant and practical. We develop right-sized solutions based on your organization’s size, resources, and regulatory needs rather than imposing one-size-fits-all templates. Our dual expertise in both device and IVD regulations ensures your QMS addresses the specific requirements for your product types.
- Can MDx provide temporary quality management services during transitions?
Yes. We offer interim quality management solutions, including part-time Quality Managers, remote QA support, and virtual teams to maintain compliance during organizational changes, growth phases, or gaps in staffing. These services can be particularly valuable during transitions between regulatory frameworks like IVDD to IVDR or MDD to MDR.
- How do you ensure our QMS will withstand Notified Body scrutiny?
Our team includes former auditors from leading Notified Bodies who conduct thorough pre-certification assessments using the same approach and standards as official audits. This insider perspective ensures we address potential issues before your formal audit. For IVD manufacturers, we have specialists in Class C and D products who understand the heightened scrutiny these products receive.
- Does MDx support MDSAP certification?
Absolutely. We have specific expertise in MDSAP requirements and provide gap assessments, documentation development, and audit preparation for all MDSAP participating regions (US, Canada, Brazil, Australia, and Japan). Our team has successfully guided multiple companies through MDSAP certification and surveillance audits.
- How do you approach risk management for different product types?
We implement tailored risk management strategies based on your specific product type and technology. For IVDs, we focus on elements like risk of false results, clinical impact, and sample handling. For medical devices, we emphasize patient safety, device performance, and use-related risks. For software, we integrate ISO 14971 with IEC 62304 and cybersecurity requirements. In all cases, we ensure documentation meets applicable regulatory requirements.
- What makes MDx's mock audits more effective than self-assessment?
Our mock audits are conducted by former Notified Body auditors who have performed hundreds of actual certification audits. They apply the same techniques, focus areas, and evaluation criteria used by leading NBs, providing authentic preparation that identifies issues self-assessments typically miss. We also tailor mock audits to your specific product types and regulatory frameworks (MDR, IVDR, FDA, MDSAP).
Expert Quality & Compliance for Your Regulatory Success
Whether you’re implementing ISO 13485, transitioning to MDR/IVDR, or preparing for a critical audit, MDx delivers the quality and risk management expertise you need for business-focused compliance and regulatory success.
Quality That Delivers. Compliance That Lasts.
