Jassy Sam

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...

Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vittles of the Drugs & Cosmetics Rules, 1945 and Drugs...

CE mark on a medical device or IVDs conforms that the device meets regulatory demand which is necessary to enter into the EU marketplace. A minor error in specialized file may delay your process of...

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...

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...

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...

What's FDA Design Control?Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design controls make a methodical...