If you are developing a new product, you need to pick standard off-the-shelf components and modules as much as possible and you need to consider compliance at this stage. If your product will include electronic components and will need to be FCC certified and/or bear a CE mark, selecting components/modules that are already certified will save you time and money. However, the question then becomes, how to make sure the certificates sent by suppliers are legitimate? I wrote some advice in … [Read more...]
New EU Medical Device Regulation: No More Traders?
If you have been buying China-made medical devices and reselling them in the European Union, and if you haven't actually done the product development work yourself, can you keep doing that business now that the new EU medical device regulation changes have come into effect? In many cases, no. … [Read more...]
You Need To Know About UKCA If You Sell Products In The UK
Many companies have been selling their products with a CE mark in the European Union and in the UK. They are in for a big shock as the UKCA mark comes into force to supersede CE in the UK! … [Read more...]