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From the drawing board to market, the regulatory path can be a tortuous one. The varying nature of novel medical devices combined with the specific risk level and designated market can often lead companies to great uncertainty. Our team of experts is here to help and guide you through any uncertainty you may encounter. From creating a regulatory strategy, designing and executing bench, animal and clinical studies, and submitting to and interacting with regulatory agencies, ProMedoss is here to help.
Development of Regulatory Strategies:
Having a comprehensive regulatory strategy is essential to allow for a better understanding of the resources required to get your product to market. A regulatory strategy is also an important document to have when trying to secure funding from potential investors. Depending on your specific needs, we can provide you with a brief localized opinion letter or a comprehensive regulatory strategy spanning various markets.
Implementing of regulatory requirements:
Once the basic regulatory plan has been outlined, it is imperative to stay on track and follow it in order to minimize resource expenditure. We can provide a variety of services to assist you in staying on track; we can assist in locating and communicating with third party laboratories, designing device specific testing as well as writing protocols and reports. We also provide clinical study management services, EDC services, data management and statistical analysis.
Submissions to Regulatory Agencies:
Once all the steps outlined in the regulatory strategy have been completed, we can assist you in compiling your submission to the various regulatory agencies. Our team has extensive experience in 510(k) and PMA submissions and we can help you to quickly and efficiently compile a submission and follow it through until clearance/approval is obtained.
We can also help in IDE and pre-sub package submissions which may be required prior to your actual 510(k)/PMA submission.