Clinical Evidence

Design EU MDR PMCF surveys that Notified Bodies accept, with sample frames, CER endpoint mapping, acceptance criteria, statistics, bias controls, and adverse event capture.

Playbook for responding to Notified Body SSCP deficiencies under EU MDR, covering response tables, clinical benefit wording, residual risk, readability, CER/IFU alignment, and EUDAMED readiness.

Apply Good Clinical Practice to medical device trials under ISO 14155:2026 and ICH E6(R3), with sponsor duties, consent, safety reporting, and audit readiness.

Plan a CLIA waiver strategy for IVDs, covering complexity categories, CW content, flex and lay-user studies, Dual 510(k) + CLIA Waiver review, timelines, and deficiencies.

Use a section-by-section EU MDR CER template covering clinical evaluation plans, literature search, appraisal tables, equivalence, benefit-risk, PMCF links, and evidence traceability.

Practical guide to digital twins, synthetic data, and computational modeling in medical device submissions, covering FDA credibility guidance, ASME V&V 40, validation limits, and documentation.

Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.

Regulatory strategy for NGS IVD devices, covering FDA pathways, EU IVDR classification, companion diagnostics, bioinformatics validation, and postmarket controls.

Use this EU MDR PMCF plan template to define objectives, methods, endpoints, timelines, reports, PMS integration, and MDCG 2020-7 traceability.

Regulatory strategy guide for surgical robots, covering FDA pathways, EU MDR expectations, autonomy levels, software controls, human factors, and clinical evidence.

Guide to the 2026 EU MDR Well-Established Technology delegated acts, expanded device lists, clinical investigation exemptions, conformity assessment changes, and manufacturer steps.

Guide to medical device benefit-risk analysis, covering ISO 14971 residual risk, EU MDR AFAP expectations, FDA benefit-risk factors for PMA, De Novo, and 510(k), examples, and documentation.

Demonstrate clinical equivalence under EU MDR Article 61 and Annex XIV, including MDCG 2020-5 criteria, data access, gap analysis, and CE marking examples.

How to design decentralized and hybrid clinical trials for medical devices, covering FDA guidance, remote visits, digital endpoints, wearable data, eConsent, and implementation planning.

Guide to validating EDC systems for medical device clinical trials, covering 21 CFR Part 11, audit trails, GAMP 5, IQ/OQ/PQ, ALCOA+ data integrity, sponsor duties, and FDA inspection risks.

Build an EU MDR literature search protocol for clinical evaluation, covering Article 61, Annex XIV, MEDDEV methodology, PICO, databases, appraisal, PRISMA, and Notified Body expectations.

Use PRO instruments in medical device trials with fit-for-purpose validation, endpoint planning, FDA CDRH expectations, EU MDR evidence, and submission strategy.

Practical guide to sample size justification for device clinical investigations, covering ISO 14155, EU MDR Annex XV, FDA IDE expectations, common study designs, and worked examples.

Build a defensible SOTA review for EU MDR clinical evaluation, with comparator selection, benchmark devices, outcome parameters, MDCG evidence hierarchy, and CER examples.

Develop a medical device SAP covering endpoints, estimands, analysis populations, missing data, sensitivity analyses, multiplicity, timing, and FDA/EU MDR expectations.