Nov 8 - 8:07
Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting...
Oct 29 - 3:31
The International Coalition of Medicines Regulatory Authorities (ICRMA) announced on Friday that they are seeking industry experts for a one year project to ensure proper awareness of track and trace systems for...
Apr 6 - 1:01
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...
Nov 1 - 7:19
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...
Jul 22 - 2:42
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...
Mar 17 - 4:43
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...
