Regulatory Services
Operational Regulatory Support
- Ethics Committee (EC) submissions – preparation, compilation and submission of study documentation, including responses to EC queries.
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Competent Authority (CA) submissions – national notifications, approvals, amendments and ongoing regulatory correspondence.
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Study documentation compliance – ensuring protocols, IBs, ICFs and site materials meet regulatory expectations.
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Ongoing regulatory maintenance – amendments, safety reporting, annual updates and end‑of‑study notifications.
Strategic Regulatory Guidance
- Device description & intended purpose – crafting clear, compliant descriptions aligned with MDR expectations.
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Device classification & conformity assessment – determining the correct class, identifying the appropriate notified body route and mapping regulatory implications.
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Systematic literature reviews (including State of the Art (SOTA)) – structured searches, appraisal and synthesis to support CERs, risk management, and clinical strategy.
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Risk Management File support – aligning risk analysis, benefit‑risk evaluation and clinical evidence requirements according to ISO 14971.
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Stakeholder engagement – gathering insights from patients, HCPs and sites to strengthen usability, adoption and regulatory justification.
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Clinical Development Plan (CDP) – defining the clinical strategy from early feasibility to pivotal studies.
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Clinical Evaluation Plan (CEP) & Clinical Evaluation Report (CER) – MDR‑compliant planning, evidence appraisal, gap analysis and full CER development.
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