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The New 510(k) Pathway: A Guide to Updated Requirements

January 6, 2021
This management report explains the new rules for selecting predicate devices, changes in device classification, opportunities for pre-submission meetings with the agency, additional postmarket testing requirements and expansion of the third-party review program.

Reliability of Medical Devices: Ensuring Availability and Safety

January 6, 2021
What are the requirements for device reliability and how can you measure it? Take your devices to the next level of reliability and achieve the best in product quality with this management report.

Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

December 7, 2020
This report brings together all the guidances, statistics and instructions you need to successfully get through an FDA inspection.

New Adverse Event Reporting Procedures: A Devicemaker’s Guide to the IMDRF Code Transition

December 7, 2020
This management report provides a detailed explanation of the new set of adverse event codes and how to adapt to the changes to the FDA’s electronic submission methods and the EU’s new reporting form.

Quality Risk Management in the EU: Concepts and Compliance

November 9, 2020
This easy-to-follow reference covers all aspects of EU quality risk management: regulatory expectations, processes, methods and tools.

Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

November 9, 2020
With this management report, you’ll discover how to move a spreadsheet toward validation, determining the best ways to conform with data integrity requirements and uncovering what FDA inspectors are looking for in a validated data analysis and reporting tool.

Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps

November 9, 2020
This management report is your GPS for data integrity compliance. It explains what data integrity is, how to protect it, how to spot problems and what the FDA expects.

GMP Inspection in the EU: Avoiding 12 Common Pitfalls

October 19, 2020
Good manufacturing practice (GMP) inspectors in the EU see the same noncompliance issues again and again. To successfully comply with EU GMPs, you must look beyond the surface of an issue to identify its root cause and consider how it impacts all other aspects of operation. Using case studies, this report analyzes where drugmakers went wrong and provides recommendations to avoid the same pitfalls.

Pharmaceutical Quality Risk Management: Navigating New Regulatory Requirements

October 19, 2020
The COVID-19 pandemic is making it more difficult for pharmaceutical manufacturers to maintain production levels and meet regulatory requirements. With this report you can make your quality risk management (QRM) efforts more effective. By using our expert tips, you will be able to determine which risks you need to manage, how to consistently apply risk management principles, and ways to implement a successful QRM plan.

Data Integrity in Clinical Trials: Ensuring Valid Results

October 19, 2020
Now is the time to examine your data practices and close gaps to protect the integrity and validity of your clinical trial results. This newly updated report will show you how.

Devicemaker’s Guide to EU-MDR: 71 Worksheets for Manufacturing Compliance

September 11, 2020
The EU Medical Device Regulation (EU-MDR) is complex and confusing yet you must comply by May 26, 2021.This report makes your task easier by transforming the EU-MDR’s 17 annexes into 71 section-by-section worksheets describing the requirements, listing the tasks necessary to be compliant along with providing space for you to document the steps your organization has taken.

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.

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