The U.S. Food and Drug Administration (FDA) announced on 22 February 2022 that it would issue a proposed rule to align its current Good Manufacturing Practices (GMP), requirements for medical devices...
Roche Diagnostics is the first manufacturer to score certification for a class D product under the new in vitro diagnostic regulation (IVDR). TÜV SÜD Product Service issued the IVDR certificate. TÜV...
A Drug Master File (DMF), a document submitted by the FDA, contains a lot of potentially confidential information regarding where, how and why drugs are manufactured and stored for human consumption...
CE mark is abbreviated as Conformitè Europëenne which is a French term. Ce mark is defined as the European Union`s mandatory conformity marking for regulating the goods sold in European Union`s...
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