CarlsbadTech’s FDA Medical Devices Regulatory Advisers

Medical device manufacturers are required to adhere to FDA and other standards for all new and improved medical devices. The FDA has three classifications for medical devices, namely, Class I, II and III. An FDA Medical Devices Regulatory Adviser can help you determine the appropriate classification of the device, and comply with imposed restrictions and regulations. Our team of experienced advisors can help you all through the FDA regulatory pathway and even offer post-marketing advice and assistance.

Studies show that the market-life for a new medical device is around 18 months before competitors start selling alternatives. It is imperative to avoid delays by identifying and managing regulatory issues early to launch your device successfully in the market. Our team of medical professionals and FDA Medical Devices Regulatory Advisers will familiarize you with the current regulatory laws, provide medical know-how and assist you to get the needed funding. With decades of experience in this field, we will be with you from start to end, helping you to negotiate effectively and speedily to launch your medical product or device.

Some of the key services we provide:

• 510(k) Premarket Notifications
• Investigational New Drug Applications (INDs)
• Investigational Device Exemption Applications (IDEs)
• Premarket Approval Applications (PMAs)
• Biologic License Applications (BLA)
• 513(g) Requests for Classification
• Technical and Design Dossiers

The FDA has increased expectations in the area of medical devices and drugs and it is vital to be prepared with the necessary regulatory and compliance requirements. Missing information in your FDA submission and documentation can lead to unprecedented delays and failures. Our skilled FDA Medical Devices Regulatory Advisers have knowledge of the most recent updates from the FDA with respect to 510(k) and PMA issues, quality systems and device labeling. In addition, our medical experts have vast experience in pre-clinical testing strategy, clinical trial design, and reimbursement.  Our range of services includes submissions (e.g. 510(k)), enforcement laws, medical consultancy, complaints or recalls, risk management, safety, documentation and much more. Contact us today for a free quote.