Protocol / Study Design
Our extensive experience and knowledge can help you plan a optimal study design. In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts. Let us be your bridge to the key opinion leaders and surgical experts throughout Europe.
FDA Regulatory Strategy
The FDA regulatory procedures are complex, though imperative for US market access. An efficient review and approval of your clinical trial, or a short route to market clearance, can only be obtained with adequate knowledge of the procedures employed at the agency and a well-designed regulatory strategy. Factory’s team has a broad and in depth knowledge on FDA requirements and procedures and can help you design a regulatory strategy specific for your device.
Timelines and Budgetary Control
Controlling development timelines and budgets are essential for companies that want to bring a medical device to the market. Factory’s control systems give you all the information you need to keep you informed and stay in control of the process, every step of the way.
European Regulatory Strategy
In many cases it is easier, faster and cheaper to obtain your CE mark (which provides marketing approval for Europe) than an FDA approval. And in most cases, equivalent clinical studies are less expensive in Europe than in the USA. Many of our clients have exploited these two advantages in order to begin marketing their product in Europe prior to FDA submission. Further, Factory can often help clients conduct European studies, which accelerate FDA submissions. We would be happy to provide a free consultation about your European regulatory strategy, without any future obligation. We can assist with Notified Body selection and negotiations.
We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies. Our strategic establishment in Europe with ISO9001-2008 certified Standard Operating Procedures that comply with the ISO14155 standard will provide you great advantage.