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Risk Management for Devicemakers: New Requirements in ISO 14971

September 11, 2020
You must be ready to implement the revised requirements in ISO 14971:2019 and EN ISO 14971:2019 within your risk management system by December 2022. This report provides all the details on ISO 14971:2019.

Supplier Management for Devicemakers: Qualification, Contracts and Audits

September 11, 2020
Devicemakers must choose their suppliers wisely and exercise careful oversight. This report will enable you to pick the highest-quality and most reliable firms and how to hammer out a contract that will hold the supplier to your standards.

Supplier Management for Drugmakers: Qualification, Contracts and Audits

September 11, 2020
Drugmakers must choose their suppliers wisely and exercise careful oversight. This report will enable you to pick the highest-quality and most reliable firms and how to hammer out a contract that will hold the supplier to your standards.

Company Core Data Sheets and Benefit-Risk Evaluations: A Drugmaker’s Guide to Postmarket Safety Reporting

September 11, 2020
Your company core data sheet (CCDS) must be a dynamic document, providing up-to-the-minute information on indications, pharmacology and safety. This report walks you through the CCDS and the Periodic Benefit-Risk Evaluation Report (PBRER), with a comprehensive explanation of FDA, EMA and ICH requirements for CCDS files and PBRERs.

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.

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