Apr 6, 2017
Africa
You don’t ask your sales team to offer you regulatory guidance. So why do you rely on your distributor to handle all your regulatory burden? First of all, it’s not so simple to register medical device abroad. Access to customers sometimes requires...
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Nov 1, 2016
Africa
Introduction The client is a Fortune 100 company that manufactures a surgical device among other products. Their objective was to launch their surgical device in Russia as soon as possible. Business Challenge The client has a local office in Russia. They still decided...
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Jul 22, 2016
Africa
Imagine you are following a controversial political scandal. What would you do? Watch the news unfold on only one channel, or pick up the TV remote and jump between multiple channels? Collecting accurate, reliable and in-depth data is the most crucial goal for...
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Mar 17, 2016
Africa
General Context UDI is a Unique Device Identifier in the form of a unique number or alphanumeric code. It consists of plain text and AIDC (only readable via machine) Issued by an FDA-accredited issuing agency. UDI is granted for 3 years and can be renewed upon...
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Oct 20, 2015
Africa
The 1960s are a time remembered either fondly or distastefully, depending on your designated family historian. If a friend or family member happens to be a medical professional, they will note one important event in their field which lay audiences may not be entirely...
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Aug 13, 2015
Africa
Karen M, one of our Switzerland-based consultants, recently shared her insights into emerging markets of medical device with us. Here are Karen’s five tips to consider before sending your product to a new or developing market: Understand existing regulations...
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