by adminReaktio | Nov 7, 2024 | Medical Device Services
What you need to know about FDA Approval processes 510(k) Clearance (Premarket Notification) The 510(k) process involves submitting a device to the FDA to determine if it is substantially equivalent to a legally marketed device that is not subject to Premarket...
by adminReaktio | Nov 7, 2024 | Medical Device Services
Our Comprehensive CER Services include Clinical Evaluation Plan (CEP) Development We create a detailed CEP that outlines the strategy and methodology for your device’s clinical evaluation. This plan defines the scope of clinical data to gather (such as...
by adminReaktio | Nov 7, 2024 | Medical Device Services
Our CE-Mark Services Include Document Structure Setup We set up a structured document system for your Technical File, considering product-specific requirements and ensuring that every Technical Document is organized for efficient review Prefilled Technical File...
by adminReaktio | Nov 7, 2024 | Medical Device Services
Our Auditing Services Include Comprehensive QMS Audits We conduct detailed internal audits of your QMS to verify compliance with important standards such as ISO 13485. Our team is also experienced with related standards like ISO 9001 (general quality management), ISO...
by adminReaktio | Nov 7, 2024 | Medical Device Services
OUR PRRC SERVICES INCLUDE Regulatory Expertise Our PRRC professionals have extensive experience and qualifications in regulatory affairs and quality management systems related to medical devices. This expertise is essential for navigating the complex regulatory...
