Clinical Evaluation

Description
Clinical evaluation is the backbone of demonstrating safety and performance throughout a medical device’s lifecycle. This webinar walks you through the end-to-end process of planning, conducting, and maintaining a compliant Clinical Evaluation under the EU MDR—covering methodology, literature appraisal, clinical data from your device and equivalents, gap analysis, and how clinical evidence feeds PMCF and PMS. We’ll translate regulatory expectations (e.g., MDR & MEDDEV 2.7/1 rev.4) into practical steps, share reviewer-ready CER structure tips, and highlight common pitfalls that delay approvals. Real-world examples and checklists are included to help you streamline documentation and decision-making.

What you’ll learn

How to scope, plan, and document a Clinical Evaluation Plan (CEP)
Building a defendable clinical evidence strategy (own data, literature, equivalence)
Conducting and documenting systematic literature reviews that withstand scrutiny
Risk–benefit evaluation and clinical evidence sufficiency assessments
Integrating outputs with PMCF, PMS, and the CER lifecycle
Frequent nonconformities—and how to avoid them

Who should attend
RA/QA professionals, clinical affairs, medical writers, R&D leads, manufacturers (legacy and new devices), and consultants supporting EU MDR submissions.

Format & materials
8 hours • Slide deck + templates/checklists • Live Q&A and discussion.

Date: 01/01/2025 Price: €

Clinical Investigation

Description
Clinical investigations are the cornerstone of generating clinical evidence for medical devices, providing robust data on safety and performance under real-life conditions. This webinar will guide you through the complete lifecycle of a clinical investigation — from protocol design and regulatory submission to execution, monitoring, and reporting. We’ll translate EU MDR and ISO 14155:2020 requirements into actionable steps, helping you understand when a clinical investigation is required, how to structure one effectively, and how to ensure GCP and ethical compliance. Real examples and templates will support practical application for sponsors, manufacturers, and clinical teams.

What you’ll learn

When and why a clinical investigation is required under MDR
Key principles of ISO 14155:2020 and Good Clinical Practice (GCP)
Designing a compliant Clinical Investigation Plan (CIP)
Selecting investigators, sites, and ethical committee submission best practices
Managing data collection, monitoring, deviations, and adverse events
Analyzing and reporting results for regulatory submission
Integrating outcomes into the Clinical Evaluation and PMS system
Common pitfalls and how to avoid regulatory findings

Who should attend
Regulatory affairs and quality professionals, clinical project managers, medical writers, sponsors, investigators, R&D teams, and consultants involved in clinical evidence generation for medical devices.

Format & materials
4 hours • Presentation slides + practical templates • Live Q&A and discussion.

Date: 01/01/2025 Price: €

PMCF

Description
Post-Market Clinical Follow-up (PMCF) is a key pillar of the EU MDR’s continuous clinical evidence requirements, ensuring that device safety and performance remain verified after market placement. This webinar will explain how to design and maintain an effective PMCF system aligned with MDR Annex XIV Part B and MEDDEV 2.12/2 rev.2, focusing on both proactive and reactive data collection strategies. We’ll cover how PMCF links with PMS, PSUR, and CER updates, and how to build documentation that satisfies Notified Body reviewers. Practical examples, templates, and common findings will help participants implement a robust, compliant PMCF process.

What you’ll learn

The regulatory framework: PMCF under MDR and MEDDEV 2.12/2 rev.2
How PMCF integrates with PMS, PSUR, and CER processes
Planning and preparing a PMCF Plan (PMCFP)
Conducting PMCF activities — surveys, registries, clinical data collection, and literature monitoring
Analyzing, trending, and reporting data in the PMCF Evaluation Report (PMCFR)
Defining triggers for updates and corrective actions
Common PMCF deficiencies observed by Notified Bodies and how to avoid them

Who should attend
RA/QA professionals, clinical and medical affairs staff, post-market surveillance teams, manufacturers, and consultants managing MDR compliance and clinical evidence maintenance.

Format & materials
4 hours • Practical templates and report examples • Live Q&A and discussion.

Date: 01/01/2025 Price: €

PSUR

Description
The Periodic Safety Update Report (PSUR) is a cornerstone of post-market surveillance (PMS) under the EU MDR, ensuring continuous evaluation of a device’s safety, performance, and benefit–risk balance. This webinar provides a practical, step-by-step overview of how to prepare, maintain, and submit compliant PSURs in line with Article 86 of the MDR. Participants will learn how to structure PSURs effectively, align them with PMS and PMCF data, and manage submissions through EUDAMED. Real-world examples and insights from Notified Body feedback will help you avoid common pitfalls and ensure your documentation withstands regulatory scrutiny.

What you’ll learn

The regulatory basis and purpose of the PSUR under MDR Article 86
How PSUR fits within the PMS and PMCF framework
Structuring and drafting a compliant PSUR: content, format, and frequency
Integrating data from vigilance, PMCF, trend analysis, and literature
Demonstrating benefit–risk balance and effectiveness of risk controls
Managing updates, submission timelines, and EUDAMED requirements
Common Notified Body findings and how to avoid them

Who should attend
Regulatory and quality professionals, post-market surveillance specialists, medical writers, manufacturers, and consultants responsible for MDR compliance and clinical evidence reporting.

Format & materials
4 hours • Presentation slides + PSUR templates and examples • Live Q&A and discussion.

Date: 01/01/2025 Price: €

SSCP

Description
The Summary of Safety and Clinical Performance (SSCP) is a key transparency requirement under the EU MDR (Article 32 & Annex II, Section 6.1 and Annex XIV), providing public access to up-to-date information on a device’s clinical evidence, safety, and performance. This webinar explains how to prepare a high-quality SSCP that meets both regulatory and Notified Body expectations. Participants will learn how to present complex clinical and performance data in a clear, accurate, and patient-friendly format, while maintaining full alignment with the device’s CER, PMCF, PMS, and risk documentation. The session will include structure templates, examples, and common review findings to help ensure successful approval and EUDAMED publication.

What you’ll learn

Regulatory requirements and purpose of the SSCP under MDR
Key differences between SSCPs for healthcare professionals and for patients
How to structure and write each section of the SSCP
Aligning SSCP content with CER, PMCF, PMS, and risk management files
How to handle clinical data summaries and performance claims
Translation, readability, and validation requirements before EUDAMED upload
Frequent Notified Body observations and how to address them effectively

Who should attend
Regulatory and quality professionals, clinical and medical writers, PMS and PMCF specialists, manufacturers, and consultants responsible for EU MDR compliance and documentation.

Format & materials
4 hours • Presentation slides + SSCP templates and examples • Live Q&A and discussion.

Date: 01/01/2025 Price: €