Neha's Blog (4)

The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.

The healthcare and wellness industry is shifting toward regulated, personalized,…

UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.

manufacturers now need to plan for how they will obtain a UK Conformity…

What Does a FDA 510( k) Clearance mean?

Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product…

The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. 

FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries.…