Compliance 4 Devices
Our services
We will provide you with personalized and direct attention, clearly evaluating and offering you possible alternatives so that your product travels the most suitable path, thus avoiding surprises and unnecessary costs
01
510k service
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 regard to the tests that may be requested by the regulatory body, as well as topics related to labelling user manuals, specific rules, etc.
02
Pre-evaluation
We offer our customers a prior assessment of the specific characteristics of their medical device and the possible FDA requirements; 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. Part of the cost of the pre-evaluation will be deducted from the final price of 510k, once it is contracted with us.
03
Technical support for your applications and/or Product Development
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, Bench tests, biocompatibility, procurement, reverse engineering, 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 FDA.
04
Quality System
In the case of medical devices, the FDA is governed by the GMP (Good Manufacturing Practices) expressed in the 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.
05
Agent service in the United States
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:
- Assist the FDA in its communications with the foreign company.
- Answer FDA questions related to the products to be imported by the foreign company into the US.
- Assist the FDA in coordinating possible inspections.
- If the FDA cannot communicate directly and expeditiously with the foreign company; the FDA may provide the documentation to the Correspondent and it will be considered officially delivered.
06
Q Sub Program
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.
Small business qualification
This allows a significant reduction in the fees charged by the FDA for the application of marketing authorizations
Foreign Government Certificate
Official document issued by the FDA certifying that the products were evaluated and released for sale on American territory; this is a document required by third-country regulatory bodies in case the company decides to export products from the United States.
Company registration with FDA
Essential requirement for marketing Class I, II and III devices in the United States; At Compliance 4 Devices we make the process easier for you and save time and money.
Our relationship with customers is based on clear and transparent communication
That way we'll achieve our common goal.
SUCCESS
Contacts
- 118 W Prive Circle
Delray Beach, Florida 33445
USA. - +1 561 789 2411
- +1 561 789 2411
- compliance4devices@gmail.com
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