REGULATORY AND COMPLIANCE
Reltronics Technologies takes pride in their knowledge of the FDA and the ISO standards. We specialize in consulting on cGxP, which comprises of Current Good (Manufacturing, Clinical, Laboratory) Practices. We ascertain that the customer identified system that is supposed to be deployed for manufacturing, is validated and also is field tested prior to beginning manufacturing. Reltronics Technologies has resident certified lead auditors who ascertain that the appropriate standard is met and that compliance is appropriately in focus in an organization.
Generally, the compliance organization assures that the suppliers and the customers are both catered to in an efficient manner. For instance, Reltronics Technologies evaluates expectations relative to the support of initial regulatory submission. The customer and Reltronics Technologies jointly identify which entity is responsible for what portion of the project including, say, regulatory filings and support. Generally, based upon the requirements of the regulatory filings, the party responsible to submit for approval is provided the technical documentation necessary to demonstrate Compliance to global regulatory requirements. If an external supplier or an OEM is identified in the project, the entity provides access to the technical documentation (on file in the supplier location) to the customer's relevant notified bodies and to competent authorities or the international regulatory authorities.
Whereas compliance findings are essential during an audit, Reltronics Technologies focuses upon long-term preventative action rather than short-term corrective actions. This approach is coupled with the risk-based approach to problem solving. Risk management plans are essential in any organization that need to comply and perform regulatory filings or acquire certification for their products.
The process of compliance and certification filing is to follow the standards documentation and, where applicable, the regulatory certifying body recommended protocols. Whereas the recommended protocols can be mind-boggling, it is important to note that the risk-based approach will assure integrity in the analysis and what protocol is required to support the scenario. The essence is to ascertain following the regulations and to ascertain appropriate documented proof of the verification and validation performed to qualify the product prior to being released or marketed in the field.
Reltronics Technologies experience to be part of qualifying varied types of products, including automated equipment and software releases, has allowed them to support different renditions of the regulatory and certification filings. Reltronics Technologies can assist in Software filing, medical device filing, UL/CE filing, 510(k) filing, and regulatory filing to obtain pre-market approval of various kinds of products in diverse verticals.
For more information, and to obtain an insight into what is required to deploy your product, please email us at info@reltronicstech.com .
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