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Clinical and Performance Evaluation Under EU-MDR: New CE Mark Rules

August 5, 2020
This report outlines the new requirements and provides details on how to perform the necessary evaluations and prepare the resulting reports. It describes common pitfalls companies face in making their case to NBs and offers recommendations for sidestepping them.

Evolving Quality Management Regulations: A Devicemaker’s Guide

August 5, 2020
This management report covers how the FDA’s quality system inspection technique will change and the inspectional authority the FDA will retain. It will discuss how EU member nations will develop their own version of ISO 13485.

Billing Sponsors for Site Expenses: How to Budget, Handle and Track Payments

August 5, 2020
This management report presents best practices for billing, collecting and auditing payments to help close gaps that funding can slip through. You’ll get advice on setting up a water-tight system, auditing your finances regularly to look for lost cash and making sure your contract with the sponsor covers every cost you’ll incur in conducting a trial.

Data Privacy in the EU: A Guide for Clinical Trial Sponsors and Sites

July 8, 2020
U.S.-based companies routinely collect and process personal data of EU-based individuals as part of their operations. Without a working knowledge of EU privacy laws and regulations, you run the risk of not being compliant.

Devicemaker’s Guide to Quality System Change Management

July 8, 2020
This management report provides a comprehensive overview of best practices, processes and methods to support medical device change management.

Postmarket Surveillance Under EU-MDR: Preparing for New Requirements

July 8, 2020
This report maps out the postmarket surveillance requirements that are spread out among various articles and annexes of the mammoth EU-MDR regulation.

Guide to Informed Consent Compliance

June 10, 2020
Guide to Informed Consent Compliance contains more than 30 FDA and OHRP documents that explain in detail what the agencies expect from sponsors and sites regarding the informed consent process.

Preparing for the EU-MDR Audit: Understanding New Requirements and Processes

June 10, 2020
Do you understand how audits of your medical device operations will be conducted? How will you work with the notified bodies doing the auditing? This management report provides a detailed explanation of the quality management auditing requirements and processes created by the EU-MDR.

Device Complaint Management: A Practical Guide to Evaluating, Investigating and Reporting

June 10, 2020
The FDA expects you to know and react immediately to reports that your device might have put someone in danger. This report outlines all the factors you need to consider in handling complaints, how they interact and how to navigate through regulations.

Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers

May 6, 2020
This management report will help you prepare, organize and streamline your audit approach so you can identify quality issues to establish a more robust operation that stands up to regulatory scrutiny.

Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances

May 6, 2020
Complying with good manufacturing practices (GMP) is mandatory for your drug’s success – sampling, testing and packaging materials all need to meet stringent regulatory standards. Set yourself up for EU success with this management report.

Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes

April 24, 2020
Without a good overview of the latest risk guidances, you may not know how to readily identify potential hazards, apply proper risk evaluation requirements or conduct pre- and postmarket assessments of your drug products and medical devices. This guide has more than 400 pages of FDA requirements and 20 specific documents that include guidances, statements and policies.

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