In Compliance 4 Devices we support you during all phases of the process of a 510K application; we review and evaluate possible comparable devices (predicates) and references; we advise in regards to the tests that may be requested by the regulatory body, as well as topics related to labelling user manuals, specific rules etc.
We offer our customers a prior assessment of the specific characteristics of their medical device and the possible requirements of the FDA: all this will allow the customer to have a clearer picture of their situation, as well as save costs, time and effort when formalizing the application; it also allows you to prepare everything at your own convenience. The cost of the pre-evaluation will be deducted from the final price of 510k, once it is contracted with us.
At the time of application of a 510k and in response to the requirements that the FDA may have for your specific product, we can help you supplement the technical information related to plans, designs, resistance tests, biocompatibility, procurement etc.
At Compliance 4 Devices we also have experience in the development of turnkey products; we go from the conceptualization, design, verification and validation phase, to having it ready to be presented to the regulatory body, as well as to the pre-marketing phase.
In the case of medical devices, the FDA is governed by the GMP (Good Manufacturing Practices) expressed in federal regulations code 21 CFR 820; which aims to ensure that medical devices in the American market are safe and effective.
In the case of companies governed by ISO 13485 whose 2018 version is very similar to the GMP, we help our customers in the adequacy and compatibility of both standards. We can also complement missing aspects as well as the complete development of your quality system according to the 21 CFR 820.
If you do not have an Official Correspondent in this country (required for any foreign company that registers or applies for a 510k), Compliance 4 Devices can gladly assist you with this; the functions of the FDA correspondent are as follows:
Through this program, promoters of medical devices and other regulated products may establish official communication with the FDA for the purpose of clarifying doubts, requirements, classification and type of submission required; it is also useful for cases where there are doubts about the interpretation of CFR 820, and about the necessity of submitting a 510k application.