Regulatory Submissions"Dealing with complexity is an inefficient and unnecessary waste of time, attention and mental energy. There is never any justification for things being complex when they could be simple" -Edward de Bono
Prior to gaining access to US and international markets, regulatory filings are required in order to establish the safety and efficacy of your products. The level of documentation varies by the risk level of the device, intended uses and country that is requesting the information. Knowing the correct regulatory route to take can be quite confusing and if the wrong path is selected, this can result in unnecessary delays and wasted money.
The first step before embarking down a particular regulatory pathway is to have an understanding of the current regulatory requirements in the target market. From there, researching any predicate devices that are currently on the market as well as any risks associated with those devices. In cases where no predicate exists, then determining the most efficient methods to establish safety and efficacy of the device, including clinical studies.
We can assist with the tedious task of researching of regulatory requirements and predicate devices, development of regulatory strategies, and with the regulatory filings themselves.
Our experience includes the following regulatory filings:
Technical file/design dossier development (EU/international)
Canadian Medical Device License (MDL)
US FDA pre-market application (PMA)
US FDA pre-market notification (510(k))