CarlsbadTech’s FDA Medical Devices Approval Consultants

The medical device and IVD (in-vitro diagnostic device) review process is complicated in the US. Going from design to marketing of a new medical device or IVD can be a tedious process. The FDA has established classifications for around 1,700 different generic types of devices and grouped them into 16 medical specialties or panels. Each of these generic types of devices is assigned to one of three regulatory classes, based on the level of control necessary to ensure the safety and effectiveness of the device.

Experienced FDA Medical Devices Approval Consultants are required to help with your FDA compliance and regulatory efforts. We offer complete FDA consulting and FDA approval services for 510k submissions, as well as for other medical regulatory requirements. Our consultants can help medical device manufacturers all over the world with FDA device classification, registration procedures, device premarket clearance, approvals and quality system compliance. The FDA Medical Devices Approval Consultant can also guide you in implementing a quality management system that is in compliance with FDA Quality System Regulations (QSR 21 CFR Part 820).

An FDA Medical Devices Approval Consultant can assist with:

• FDA 510(k) submissions
• FDA Investigational Device Exemption (IDE) submissions
• FDA Requests for Classification and Determination
• FDA Pre-Submission Meetings
• FDA QSR Consulting for Medical Device and IVD Manufacturers
• FDA QSR Training for companies
• Labeling assistance
• Assistance to meet post-approval requirements
• US Agent

FDA Medical Devices Approval Consultants will address your submission and compliance requirements, expediting approvals for your medical devices and IVDs. Our experienced consultant will prepare and submit FDA 510(k) submissions for your medical device and IVD to be sold in the United States. We have extensive industry experience in this process and assure you of a successful submission.

We have been offering professional consultancy to the healthcare industry for almost three decades. Our experienced FDA Medical Devices Approval Consultants provide FDA regulatory support for various types of firms. We provide services for all classes of medical devices and IVDs. Our consulting services will help you meet all the FDA regulatory requirements and get your device ready for sale in a short time. Contact Us for further information.