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Home / 2017 / October

Monthly Archives: October 2017

hands all in together
30Oct

Being a Great Team Member

  • Rich Gall
  • Leadership Development, Project Management/Leadership

October 30, 2017 Leadership Development, Project Management/Leadership There are multitudes of articles and books that contain advice on how to be a great leader. But what if you’re like most of us and not at the top of the food chain? In most teams, there is one leader and a team of people doing the work. While we like to place the responsibility for a project’s success or failure on the leader, every team member has ownership and influence on how a project turns out. Your contribution to the project must…
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Wheels turning inside head
25Oct

MEDDEV 2.7.1 Rev 4, and what it means to you

  • Rich Gall
  • Information

If you manufacture a medical device that is CE marked, you are required to comply with the latest MEDDEV 2.7.1 publication. This revision is a major rewrite from the previous publication of Rev 3 as the authors sought to bring clarity and layout stricter expectations for Clinical Evaluation Reports (CERs). Compliance expectations ultimately fall on the manufacturer, and the Notified Bodies are being given greater responsibility in enforcement as they perform audits. Rev 4 is 50% larger than its predecessor because of the level of detail. Fortunately, the document was…
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