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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
The US Food and Drug Administration (US FDA) has proposed to amend the medical devices Quality System Regulations (QSR) under 21 CFR 820. The current QSR regulations date to 1978 and have been amended only once in 1996.
Maintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices.
Medical device’s global standard for quality management system gets a long-awaited amendment to a new standard: ISO 13485.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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