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“Wait a minute. You want me to do what?” That was the first response from Kai Lin, an employee at Mythical Medical, after being asked by senior management to set up a system to proactively oversee “significant change” processes affected by MDR Article 120, Transitional Provision. She was convinced this would be a dead-end, career-limiting,

Sharing information and insights internally from either regulatory agencies or Notified Bodies is healthy behavior. Knowledge is power, several believe. It can change the world, your company, and your personal leadership behavior, but only when it is communicated in a timely manner and shared in the right ways. Break out of your self-imposed jail today.

The coronavirus pandemic is causing hiring uncertainties. It may become more difficult to conduct face-to-face hiring interviews. Also, laws, regulations, standards, and guidance documents are changing worldwide. Expectations are, too. Yet an encouraging, long-standing, and reassuring truth remains that can help with these challenges. Identify specific, key qualifications so that your team can be strengthened.

Benefit-to-Risk Analyses Some things make sense. They are easy, balanced, symmetrical, and predictable. That’s why Jae, an employee at Mythical Medical, liked mathematics, engineering, chemical reactions, and physics. Rules or laws are in place, and, for the most part, you follow them. Equations made sense, and he loved them. He also joined a debate club because