Procedures for FDA submission and approval are complex, requiring different strategies for each type of medical device or IVD. Adequate knowledge of the requirements of each access route is therefore essential. We have an extensive knowledge pool available, helping you through each step of the submission process.
Competent Authority submissions
Beofre conducting a clinical trial, the Medical Device manufacturer must meet certain national laws. This approval is granted by a countries national Competent Authority. With different Competent Authorities for every country come different national requirements, guidelines and timelines. Factory CRO is there to make things less complicated and help you out during your Competent Authority submission.
Ethics Committee / Institutional Review Board submissions
In certain (and most) cases, you will require Ethics Committee / Institutional Review Board approval before conducting your clinical trial. Having performed multi-center clinical trials in up to 20 different countries in Europe, the America’s and Australia, Factory CRO has extensive experience in performing regulatory submissions.
Our Medical Doctors are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.
Postmarketing Surveillance (PMS)
The transition from clinical development to marketplace introduction is critical to the success of a product. Post-marketing surveillance studies can give you the valuable information you need to optimize your product’s potential and gain competitive advantage.
Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts. Factory is eager to work with you to achieve the scientific credibility of PMS studies and to maximize your product’s exposure.