Our Pathways to Your Success
Plan strategically from design to market
Identify the regulatory requirements for medical and IVD devices and provide advice and services for compliance
Prepare and assist clients in regulatory submissions, manufacturing compliance, quality system implementation, and other regulatory requirements for most Class I & Class II devices.
After a free, one-hour consultation regarding your project, if you decide to use our services, we will set up a project plan for your device(s). This can involve regulatory submissions, manufacturing compliance, quality system implementation, and other regulatory requirements for most Class I & Class II devices.
We will then identify faculty experts and student employees who may may provide assistance according to your needs. A comprehensive project plan can be particularly important if you are applying for a grant and need letters or text regarding our contributions.
We provide advice and services to students, faculty, and industry with interesting products, and anyone else who might need a little extra help navigating the world of quality systems and regulatory affairs. This includes:
Quality Management System (QMS) Implementation
Required for manufacturers to have for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution. Standards available for implementation include:
- 21 CFR 820
- ISO 13485
The scientific principles upon which a device is based are fundamental to its safety and performance. The more complex the device, the higher the risk of the user error. Soundness of concept and adequacy of design, construction and testing require the scrutiny of scientific experts to ensure that design parameters and performance characteristics do not impose unwarranted risks.
The quality system regulation (21 CFR 820) includes design controls which must be complied with during the design and development of the device. Design control is a systematic way to follow product design from user requirements to final product.
FDA Filing and Approval
Before a medical device can be marketed in the USA a marketing application must be submitted to the FDA and clearance obtained.
- Exemptions: Most Class I devices and a few Class II devices are exempt from the requirement for submission of a marketing application. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.
- 510(k): Most Class II devices require Premarket Notification 510(k). A 510(k) is a pre-marketing submission made to FDA to demonstrate that the device to be marketed is safe and effective, and substantially equivalent, to a legally marketed device. If your device requires the submission of a Premarket Notification 510(k) you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing, you to do so.