New UKCA Mark As It Pertains To Medical Devices

New UKCA Mark As It Pertains To Medical Devices

The UK Conformity Assessed Mark (UKCA) is the new United Kingdom (UK) product mark that will be used for certain goods being placed on the market in Great Britain (GB – England, Wales and Scotland), following the UK’s exit from the European Union (EU). The UKCA...
Product Recalls

Product Recalls

Author:Jeff Baum A product recall occurs when a company has sold a product that is deemed defective or a safety hazard and is then responsible for pulling the product off the market and fixing it or removing it altogether, at the cost of the company. Recalls occur for...
Risks of Global Noncompliance

Risks of Global Noncompliance

Many manufacturers choose not to obtain required wireless or safety certifications for their devices going into global markets for various reasons. While those reasons might seem valid, and are definitely based on value, the risks of noncompliance can far outweigh the...
Late-to-Market Loss

Late-to-Market Loss

Timeliness and efficiency Successfully introducing a product to market involves having timeliness and efficiency on your side. It means launching the product in an armor of testing, product approvals, distribution, operations, and more. Despite the risks associated...
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