Jan 28 - 2:02
Manufacturers and distributors are two separate entities with the same goal in mind– they both want to sell medical devices. Manufacturers want to sell the products that they produce, but because they often have no...
Jan 24 - 4:16
The British Standards Institution (BSI) United Kingdom (UK) has been officially designated as the first notified body (NB) under the Europe Union’s (EU) new Medical Device Regulation (MDR). This is the first NB to be...
Jan 23 - 8:42
The majority of medical devices sold in Japan are paid for by the Japanese National Health Insurance (NHI) system via reimbursement, which is oftentimes an even more critical matter than regulatory compliance. In order...
Jan 23 - 7:14
After weeks of the government’s shutdown, the US Food and Drug Administration (FDA) has announced that more workers will be returning to work without pay. A large majority of these workers are inspectors or work to...
Jan 21 - 8:13
Oftentimes, medical device manufacturers spend so much time attempting to comply with the complex regulations of their target markets that they fail to direct enough attention toward picking the right distributor for...
