Medical Device Consultant-AI-powered medical device consultancy.

Example

Assisting a company in determining the appropriate FDA submission type (e.g., 510(k), PMA, or De Novo) for a new medical device.

Scenario

A small medical device company is preparing to introduce a new surgical tool to the U.S. market. The Medical Device Consultant evaluates the product's risk class, compares it with existing devices, and recommends the most suitable regulatory pathway, such as a 510(k) submission, along with a detailed checklist of required documentation.

Example

Advising a company on implementing ISO 13485 quality management systems to ensure their products meet international standards.

Scenario

An established manufacturer expanding into the European market needs to align its quality management system with ISO 13485. The Medical Device Consultant provides a step-by-step guide on integrating the required processes, documentation, and controls into their existing systems, ensuring smooth certification.

Example

Guiding a development team in implementing robust design controls and risk management processes according to ISO 14971.

Scenario

During the development of a new patient monitoring device, the Medical Device Consultant helps the engineering team establish design controls, create a risk management plan, and conduct failure mode and effects analysis (FMEA) to minimize potential risks associated with the device.