Frequently Asked Questions

• How long does it typically take to remediate technical documentation for MDR/IVDR compliance?

  Timelines vary based on device class and documentation maturity but typically range from 3-8 months for complete technical documentation remediation. Our assessment phase provides a precise timeline for your specific product.

• Can MDx support both IVD and medical device technical documentation in the same project?

  Yes. We have specialized teams for both IVDs and medical devices, with experts in specific technology areas like software, combination products, and companion diagnostics. For products with both components, we provide integrated support with teams working in parallel.

• What advantages do former Notified Body reviewers bring to technical documentation development?

  Our former NB experts understand exactly how submissions are reviewed, common deficiencies, and what constitutes acceptable evidence. This insider knowledge ensures documentation is structured optimally, addressing potential concerns before they become findings.

• How do you stay current with evolving regulatory requirements?

  Our Regulatory Intelligence team continually monitors updates from authorities (EMA, FDA, MHRA), notified bodies, and industry groups. We maintain relationships with regulatory bodies, participate in industry working groups, and immediately incorporate new guidance into our processes.

• Can you support global submissions beyond EU and US markets?

  Yes. We support submissions in major and emerging markets worldwide, including UK, Canada, Australia, Japan, Brazil, and China. Our global regulatory strategy ensures efficient leveraging of core documentation for multiple markets.

• What is your approach to GSPR compliance documentation?

  We follow a systematic approach to GSPR compliance, mapping applicable requirements, identifying relevant standards, assessing compliance with each requirement, and documenting evidence. Our approach ensures complete traceability between requirements, standards, and verification evidence.

Frequently Asked Questions

• What is the difference between analytical and clinical validation?

  Analytical validation confirms that an IVD accurately, reliably, and consistently measures the analyte of interest (e.g., sensitivity, specificity, precision). Clinical validation assesses how well the test identifies a clinical condition in the target population. Both are required for IVDR and FDA submissions.

• Can MDx help with APR creation and IVDR Analytical Performance Reports?

  Yes. We provide full APR development, including statistical analysis, summary writing, and formatting for IVDR and FDA requirements.

• Do you support CLSI-compliant documentation?

  Absolutely. Our protocols and reports are aligned with CLSI standards (EP05, EP17, EP25, etc.), ensuring global regulatory acceptance.

• What types of technologies do you support?

  We cover PCR, NGS, immunoassays, IHC, multiplex, lateral flow, SaMD, and more.

• How quickly can an analytical validation study be completed?

  Timelines depend on assay complexity and sample availability, but most studies are completed in 2–6 months with MDx CRO’s project management.

Frequently Asked Questions

• What is the SRD vs NSRD decision for CDx in the US?

  The FDA distinguishes Significant Risk Device (SRD) from Non-Significant Risk Device (NSRD) studies. We guide CDx sponsors through Q-sub interactions and determine the right path toward PMA or other submissions.

• What is IVDR Annex XIV for companion diagnostics?

  Annex XIV defines the clinical performance study requirements for IVDs, including CDx, in the EU. It covers submissions, ethics/competent authority processes, and evidence expectations for IVDR conformity assessment.

• Can MDx act as legal representative for CDx and IVDR performance studies in the EU?

  Yes. We offer delegated sponsor services, ethics/competent authority submissions, and legal representation — managing documentation and communications on your behalf.

• Do you support both IVDR and FDA PMA or Q-submissions for CDx?

  Absolutely. We define submission strategies, coordinate evidence generation, and manage end-to-end communications with EU Notified Bodies, EMA, and the FDA, including FDA PMA/Q-submissions and IVDR Annex XIV applications.

• What challenges exist when running combined studies under both CTR and IVDR?

  Combined studies face regulatory misalignment — IVDR and CTR have different requirements, timelines, and submission pathways. MDx helps sponsors navigate these complexities by developing integrated strategies, ensuring both clinical and performance data meet the distinct expectations of medical device and medicinal product regulators.

Frequently Asked Questions

• Do you manage both IVD and Medical Device studies?

  Yes — across MDR, IVDR, FDA IDE, IRB, and more.

• Can MDx act as Legal Representative in the EU?

  Yes — under MDR (Art. 62.2) and IVDR (Art. 58.4), we can act as legal rep or delegated sponsor. We also provide UK RP services.

• Do you support software as a medical device (SaMD)?

   Yes. We support digital therapeutics, diagnostics, and SaMD studies with IEC 62366-aligned usability testing and FDA Human Factors guidance.

• What’s the difference between a clinical trial, investigation, and performance study?

  Clinical trial = general term
  Clinical investigation = for medical devices
  Performance study = for IVDs
  We support all — from feasibility to full submissions.

Frequently Asked Questions

• What qualifications do your trainers and consultants have?

  Our team includes former notified body reviewers from BSI and TÜV SÜD, and industry experts with 15+ years of experience in regulatory affairs, quality management, and clinical evaluation. Many are active in industry working groups and standards committees, ensuring our guidance reflects current regulatory thinking. We’re also selected by multiple European Notified Bodies to train their own assessors on IVDR and MDR requirements.

• How do your FDA 510(k) consulting services differ from other consultants?

  Unlike generic regulatory consultants, our FDA submission experts have direct experience with successful 510(k), De Novo, and PMA submissions across multiple device categories. We provide end-to-end support from pre-submission strategy through response management, with a proven track record of first-time clearances. Our approach integrates regulatory strategy with quality compliance and clinical evidence development for comprehensive submission packages.

• Do you offer certification for completed training programs?

  Yes, participants receive certificates of completion for all formal training programs. For certain specialized courses, we offer competency-based certification that includes assessment of practical skills and knowledge application. These are valuable for demonstrating regulatory competence to notified bodies and during quality system audits.

• Can you provide consulting services remotely?

  Yes. While some projects benefit from on-site presence, we routinely provide highly effective consulting services remotely using secure document sharing platforms, video conferencing, and collaborative tools. This approach often reduces costs while maintaining quality and engagement, especially for document reviews and strategic consulting.

• How quickly can you develop custom training for our team?

   For standard topics with customization, we can typically prepare and deliver training within 3-4 weeks. For highly specialized programs, 6-8 weeks allows for thorough needs assessment, material development, and review. For urgent needs, we offer accelerated options using our pre-developed modules with light customization.

• Can you provide IVDR/MDR transition strategies and gap assessments?

  Absolutely. This is one of our core specialties. We offer both comprehensive training programs to build internal knowledge and consulting services to develop and execute transition strategies. Our approach includes document gap assessments, remediation plans, timeline development, and project management support tailored to your specific products and business needs.

Frequently Asked Questions

• At what stage of product development should we start usability engineering activities?

  Ideally, usability engineering should begin in the earliest concept phases. However, we regularly support clients at all stages-including those who need to remediate existing products or documentation to meet current requirements. Starting early typically reduces costs and development time by identifying issues before they become embedded in your design.

• What's the difference between formative and summative usability testing?

  Formative testing is iterative, conducted during development to identify and resolve usability issues. It’s less formal and focused on improvement. Summative testing is a formal validation conducted near the end of development to verify that the final design meets safety and effectiveness requirements. Both are required by IEC 62366 and FDA guidance, but serve different purposes in your development process.

• How does MDx handle international usability testing for global markets?

  We maintain a network of testing facilities and participant recruitment capabilities across key global markets including the US, major EU countries and UK. We coordinate multi-site studies with consistent protocols while accounting for cultural and linguistic differences, ensuring your device is validated for all target markets.

• How much documentation is required for usability engineering under IVDR/MDR?

  The documentation requirements are substantial but vary based on device classification and intended users. At minimum, you’ll need a Usability Engineering Plan, use specification, formative testing reports, and a Usability Engineering File with a summative evaluation report. For higher-risk or lay-user devices, additional documentation is typically required. Our approach ensures you have exactly what’s needed for your specific device classification.

• Can you support FDA human factors submissions for medical software?

  Yes. We have specific expertise in validating software as a medical device (SaMD), mobile medical applications, and software components of hardware devices. Our approach conforms to FDA’s guidance on human factors for medical software and digital health technologies, including appropriate documentation for various submission pathways.

• How do you recruit appropriate test participants for specialized medical devices?

  We use a proven participant recruitment methodology tailored to your specific user groups. For specialized devices, we work with healthcare professional networks, patient advocacy groups, laboratory networks, and specialized recruitment agencies. We rigorously screen all participants to ensure they accurately represent your intended user population in terms of experience, training, capabilities, and demographics.