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Regulatory Compliance Requirement Articles & Analysis
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At Proregulations, a company that specializes in assisting with regulatory compliance, we offer U.S. Cosmetics Registration services designed to ensure that cosmetics meet U.S. regulatory requirements, reduce compliance risks, and expedite the product launch process. ...
Clinically, the treatment of NK is very complicated, and there is a lack of effective and affordable treatment options. This is an important regulatory milestone that enables us to bring this potentially transformative treatment to patients sooner. ...
“Align Technology is pleased to have resolved these disputes with 3Shape,” stated Julie Coletti, senior vice president, Chief Legal and Regulatory Officer. “We will continue our focus on innovation, including technologies such as the award-winning iTero Element 5D imaging system which aids in the detection and monitoring of interproximal caries lesions above the ...
Factors that might cause such a difference include, but are not limited to: the impact of the COVID-19 pandemic on the health and safety of our employees, customers, patients, and our suppliers, as well as the physical and economic impacts of the various recommendations, orders, and protocols issued by local and national governmental agencies in light of continual evolution of the pandemic, ...
Factors that might cause such a difference include, but are not limited to: the impact of the COVID-19 pandemic on the health and safety of our employees, customers, patients, and our suppliers, as well as the physical and economic impacts of the various recommendations, orders, and protocols issued by local and national governmental agencies in light of continual evolution of the pandemic, ...
Continued Strong Growth and Increasing Momentum for Invisalign Clear Aligners and iTero Systems and Services Across Products and Customer Channels Worldwide, Reflects the Strength of Align’s Doctor-Directed Model and the Align Digital Platform $99.7 million award includes the $54.2 million paid to Align to date for the capital account SDC required to pay $45.5 million ...
MDSAP is a program that allows for one regulatory audit of a medical device manufacturer’s quality management system (QMS) that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP ...