Cleanrooms are a specially designed environment in every medical industry or food packaging industry etc, to avoid small particles interfering with the manufacturing process.A clean room is an area...
Saudi Arabia is famous as one of the largest market for the medical device. Due to the hydrocarbon-based economy and As part of the Gulf Cooperation Council (GCC, also known as the economic union of...
Contract Manufacturing is a type of outsourcing in which a company creates whole products or a single part a larger product. This is valid in the medical device industry, too. OEM (Original Equipment...
Post Market Clinical Follow (PMCF) up is an effective method that constantly helps to monitor the clinical evaluation results. This assessment and examination of clinical information relating to the...
FDA 21 CFR Part 820 covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labelling, storage, installation & servicing of medical devices...
Regulatory PathwayFDA (Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services, and also a federal executive department of the United States. The...
If you are medical device manufacturer and looking for FDA for your device then read our complete article to know about FDA, FDA approval process, the time required for FDA approval.In the United...
Author Bio
Medical devices consultant