Client Details: Client is a large scale, multi-industry conglomerate that markets filtration devices worldwide. Problem Statement: Client’s product leadership is […]
Client: The client, a pioneering European company specializing in advanced medical technologies, sought regulatory approval for its innovative Holographic 3D
The Quality System Regulations (QSR), outlined in 21 CFR Part 820, are critical guidelines established by the U.S. Food and
Artixio provides expert regulatory staff on contingent and contract basis to pharmaceutical and other lifesciences industries using both its in-house
Client: Client is a global medical devices leader with strong presence in syringes market. Problem Statement: The Company’s R&D department
In 2022, the Europe biosimilar market had a value of almost USD 4601.56 million. In addition, it is anticipated that
Structured Product Labeling format is used to submit the labeling content in electronic format. It is a standard document used
FDA classifies medical devices into different categories based on their risk factor. Each class of medical device holds different rules and regulations as every one of you would
As we know, the healthcare system and medical devices are co-dependent. The safety and effectiveness of medical devices matters when
