September 25, 2019

[FEATURED] It Is A Great Time to Move Within Regulatory – Especially If You Know What To Expect

The demand to fill EU regulatory roles is at its peak and is dictating the very nature of employment in the medtech sector. Amanda Maxwell spoke with recruitment expert Elena Kyria to hear her views on how to maximize the unique opportunities that currently exist. This is Part 1 of a three-part interview series on recruitment in medtech. 

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September 12, 2019

[FEATURED] Global Call To Rethink MDR Timing Sees Commission Dig Heels In Further

The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on the international front, with the US, for one, wanting to see a three-year postponement. Is the European Commission right to remain stubbornly attached to its deadline?

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August 7, 2019

[FEATURED] Two More Notified Bodies About To Be Designated And Surge In Publications Of New Documents

The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.

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July 15, 2019

[FEATURED] No Need For UDI On Some Drug/Device Combinations In The EU

While UDI will be required on all products that come under the scope of the EU’s medical device regulations, what is the situation for drug/device combinations? The answer is not simple, and depends on an often-tricky regulatory assessment.

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June 13, 2019

EU Officially Designates Second Notified Body Under The MDR: TÜV SÜD Enters Center Stage

TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?

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Generis American Medical Device Summit 2019

Oct 28-29, in Chicago, IL

Join our President Laurie Mitchell at the AMD summit as she leads a session on day 2: Systematic Literature Review: How to Empower Data-Driven Decision Making.

Interested in discussing regulatory or medical writing projects? Book a free consultation with President Laurie Mitchell and CEO Lalitha Jonnavithula at booth #13, where you can sign up for the chance to win a FREE Amazon Echo!