New Regulations, New Timelines: How Chemistry Changed in Response to ISO 10993-18:2020

Regulatory expectations are always evolving to enhance medical device safety, and the publication of ISO 1099318:2020 (part 18) demonstrates the importance of staying up to date on the regulatory landscape. Understanding what part 18 means for device material identification expectations and chemical characterization studies is crucial for a successful submission and, ultimately, a product’s overall life cycle. Furthermore, a firm grasp on the requirements can influence how manufacturers approach timelines and budgets, saving them time and money down the road.