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The new medical device/in-vitro diagnostic regulations are finally adopted in EU

The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally. The revised rules also provide the conditions needed to consolidate the role of the EU in the long-term as a global leader in the sector.

Read the EC Press release

Block 22 May 10.00-11.30 and 7 June 15.00-16.30 for our Webinar presenting the news and essentials.   www.key2compliance.com/cs5002.php


Anna Lundén talks about Tendencies and developments to be found in observations and warning letters - Video

Anna Lundén, training director and part owner, Key2Compliance AB discuss with Henrik Johanning, CEO, Genau & More.

Final Guidance on CGMP Requirements for Combination Products published

The draft document was issued January 2015 and is now published as final. This guidance describes and explains the final rule on current good manufacturing requirements for combination products (21CFR4) that FDA issued on January 22, 2013.

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Current Challenges in Implementing Quality Risk Management

New article from James Vesper and Keven O’Donnell published in Pharmaceutical Engineering, Nov-Dec 2016.
From the content:
"The intent of QRM is to make data-driven and scientifically sound decisions proactively, not to justify an action or a decision that has already been taken"
"Formal risk assessments sometimes fail to add value or clarity to a situation because risk assessments often only superficially address root cause analysis, resulting in ineffective risk-control actions"
"Some firms have not yet seen that hazard identification and risk assessment tools can be used together synergistically"

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Related course: "Quality Risk Management - Applying the principles and tools", May 8-9, 2017, Copenhagen, Denmark