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The world of clinical investigations is changing rapidly, with the EU-MDR’s new and more complex system and the forthcoming ISO/DIS 14155:2018 updates. This presentation will provide insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. View

Devicemakers that export into Canada, Japan, Australia and Brazil face important changes to the audit and inspection process as the new Medical Device Single Audit Program (MSDAP) goes into effect. View

The FDA’s 510(k) design change guidance documents are not the easiest to understand and incorporate. While the guidance’s flowcharts were designed to help guide evaluation and decision-making, they can instead be confusing. This presentation will provide you with a clear understanding of the decision paths and processes. View

This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View

The EU-MDR Transition: Meeting the CE Mark Deadline explains how to take advantage of the soft transition to the new regulation. The soft transition allows companies to retain certain aspects of the current CE Mark applications while following new registration requirements, if their notified bodies approve. View

Implementing compliant systems for medical devices with animal tissue requires multiple control layers, typically using standards in the ISO 22442 family — some of which are under revision. View

Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View

The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size. View

James “Gunny” Shore — the Chief Quality Officer at Quality Lean Solutions — literally wrote the book on QMS (Proactive Supplier Quality Management in the Medical Device Industry), and he is here to teach you what you need to create a world-class quality system.

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The Investigations Operations Manual is the primary policy guide for FDA investigations and directs the conduct of all fundamental field investigational activities. View

Perch on the shoulder of an expert to discover potential pitfalls and innovative approaches. Get feedback, resolve pain points and share experiences in real time. View