Medical Device

USFDA Compliance Services

Medical Device / IVD (USFDA Registration)

GAMP GROUP is a trusted partner offering specialized services for USFDA registration of medical devices and in vitro diagnostic (IVD) devices. Navigating the complex regulatory landscape in the United States can be challenging for manufacturers, but with GAMP GROUP’s expert guidance, companies can streamline the process of getting their devices approved for the US market. The services cover every essential aspect of the USFDA registration process, ensuring that medical device companies meet regulatory standards efficiently and effectively.

One of the cornerstone services provided by GAMP GROUP is USFDA Establishment Registration. In the US, manufacturers, contract manufacturers, and importers of medical devices are required to register their establishments with the USFDA. GAMP GROUP helps clients complete this mandatory registration, ensuring that all relevant establishments are properly listed and in compliance with federal regulations. This service guarantees that companies can legally manufacture, distribute, or import medical devices in the United States.

In addition to establishment registration, GAMP GROUP also offers USFDA Premarket Notification (510k) Consultation. For most Class I and II devices, a 510(k) submission is required before the product can be legally marketed in the US. This premarket submission demonstrates that the new device is substantially equivalent to a legally marketed device. GAMP GROUP guides companies through this rigorous process, from identifying a predicate device to preparing all necessary data and documentation. Their expertise ensures a smoother path toward product clearance by the USFDA.

GAMP GROUP also specializes in 510k Documentation and Device Master Files. Accurate and comprehensive documentation is critical for FDA approval. The 510(k) submission requires detailed device descriptions, technical data, performance testing results, and labeling information. GAMP GROUP assists companies in compiling the required documents and structuring the device master files, ensuring all data are in line with USFDA expectations.

Another crucial service offered is Medical Device Unique Device Identification (UDI) Listing. The USFDA mandates that most medical devices bear a unique device identifier (UDI) to improve the traceability and safety of medical devices. GAMP GROUP facilitates this listing process, helping companies assign proper UDIs, ensuring their devices are identifiable and traceable throughout their lifecycle in the marketplace.

In addition to these regulatory services, GAMP GROUP also provides MDSAP (Medical Device Single Audit Program) services. MDSAP allows a single audit of a medical device manufacturer to satisfy the regulatory requirements of multiple countries, including the USFDA. GAMP GROUP supports companies in preparing for and passing these audits, helping to expand their global reach by ensuring compliance with regulatory requirements in the US, Canada, Brazil, Japan, and Australia.

By offering a comprehensive suite of USFDA registration services, GAMP GROUP positions itself as a key partner for medical device and IVD manufacturers seeking entry into the US market. Their expert guidance on establishment registration, 510(k) submissions, UDI listing, and MDSAP audits ensures that their clients meet all regulatory requirements while minimizing the time and complexity typically associated with these processes. With GAMP GROUP’s support, medical device companies can focus on product innovation and market expansion, while being confident that their regulatory compliance is in trusted hands. USFDA Establishment Registration.