Compliance in 2020 and beyond
2020 is expected to bring increased scrutiny and tighter regulations to medical device and diagnostics companies across the globe. The looming EU MDR deadline in May and subsequent IVDR changes in 2022 continue to put pressure on European and US markets. That, coupled with a call for tighter US regulations, as evidenced by press that continues to accumulate, will lead to significant industry changes in 2020 and beyond.
It’s a lot of pressure, for individuals, for teams, for companies and investors, to deliver safe, compliant and quality products and solutions. And as a medical, marketing, legal or regulatory reviewer at a device or diagnostics company, your daily actions are a crucial piece of that larger story.