Regulatory Services for Medical Devices and IVDs in the USA

UDI (Unique Device Identifier) Consulting services are offered to medical device manufacturers to assist them in implementing and complying with the UDI system mandated by the U.S. Food and Drug Administration (FDA). The UDI system is designed to enhance patient safety, streamline device tracking...

US Agent services are provided to foreign medical device and drug companies that intend to market their products in the United States. The US Food and Drug Administration (FDA) requires foreign manufacturers to designate a US Agent, who serves as a liaison between the...

Pre-Market Notification, commonly referred to as the 510(k) process, is a regulatory pathway established by the U.S. Food and Drug Administration (FDA) for the clearance of medical devices for marketing in the United States. The 510(k) process is used for moderate-risk medical devices that...

Premarket Approval (PMA) is one of the most rigorous and comprehensive regulatory pathways established by the U.S. Food and Drug Administration (FDA) for the approval of medical devices. It is required for certain high-risk medical devices that do not have a substantially equivalent predicate...

De Novo Classification is a regulatory pathway for medical devices that lack a legally marketed predicate device. It allows novel devices (Class I or Class II) to gain market authorization through the US Food and Drug Administration (FDA). Unlike the 510(k) pathway, which relies...

21 CFR Part 801 is a critical regulation issued by the Food and Drug Administration (FDA) that sets forth specific requirements for the labeling of medical devices sold in the United States. Labeling includes all written, printed, or graphic materials that accompany a medical...

QSR (Quality System Regulations) Compliance Consulting is a specialized service provided to medical device manufacturers in the United States to ensure their products meet the regulatory requirements set forth by the Food and Drug Administration (FDA).

Q-Submission Consulting services are offered to medical device manufacturers and developers who intend to seek regulatory guidance and interact with the U.S. Food and Drug Administration (FDA) through the Q-Submission program. The Q-Submission program provides a formal mechanism for industry stakeholders to obtain feedback...