Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation
By Yvonne Middlefell, FRAPS, RAC -
Published 12 December 2017
This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.
Categories: Features, Europe, EC, In vitro diagnostics, Labeling, Medical Devices, Submission and registration
Tags: IVDR, Annex 1, Risk Management
Organizational Culture and Memory in Managing Risk in the Medical Device Industry
By Darin Oppenheimer, DRSc, Suraj Ramachandran, MS, RAC -
Published 15 August 2017
This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality."
Categories: Features, US, FDA, Business Skills, Medical Devices
Tags: Risk Management, Organizational Culture
Ethics and Risk Management: Lessons from the VW Defeat Device
By Meredith May, MS, RAC, Anna C. McFadden, PhD -
Published 12 April 2016
This article discusses risk management practices from the automotive industry and what the biomedical industry can learn from recent current events.
Categories: Features, Compliance, Crisis management, Due Diligence, Regulatory intelligence, Regulatory strategy
Tags: Risk management, Volkswagen, Defeat device,
Practical Guidance for Regulatory Professionals on Combination Products
By Suzette Roan, JD, John Towns, PhD -
Published 05 February 2016
This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities.
Categories: Features, Europe, US, EC, EMA, FDA, ICH, IMDRF, Combination products, Research and development, Submission and registration
Tags: Combination products, Design validation, Risk management, IMDRF
In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures
By Alexander Gaffney, RAC -
Published 13 March 2014
Tags: RMP, Risk Management Plan, Post-Authorization, Postmarketing, Public, Transparency, Latest News, EU
Risk Management: What Regulatory Professionals Need to Know
By Zachary Brousseau, RAPS senior manager, communications -
Published 20 February 2013
Regulatory Focus caught up with William K. Sietsema, PhD, co-editor of Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment of Medicinal Products, for his perspective on risk management principles and how the book addresses them.
Tags: risk management, risk
Book Excerpt: Risk Management in the Future: Looking Into the Crystal Ball
By Tjeerd-Pieter van Staa -
Published 06 December 2012
Pharmacovigilance has been defined by the World Health Organization as, "The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem." Pharmacovigilance (or risk management) should help to inform both healthcare professionals and patients, allowing them to make educated decisions when choosing a treatment.
Categories: Under RAPS
Tags: pharmaceutical, drug, risk management, pharmacovigilance
Risk Management for Medical Devices - A Practical Approach
By Val Theisz -
Published 22 June 2012
Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission. After recognizing that the risk management process itself is deficient, should you bite the bullet and address this more fundamental issue first, but risk delaying the submission in exchange for mid- and long-term benefits? If you decide this is the best course of action for you and your company, this article is for you.
Tags: ISO 14971, Design History File, Risk Management File, 510(k), risk, medical device
Report: REMS Preventing Companies From Making Generic Medicines
By Alexander Gaffney -
Published 23 May 2012
Categories: FDA, FTC
Tags: Risk Management Plan, Competition, Generic, Latest News, pharmaceutical, FDAAA, safety, drug, REMS, risk