by adminReaktio | Nov 7, 2024 | Medical Device Services
Key Aspects of European Authorized Representative (EC-Rep) Services Representation for Non-EU Manufacturers We act as your official representative (EC-Rep) within the European Union, a mandatory requirement for non-EU manufacturers under the EU Medical Device...
by adminReaktio | Nov 7, 2024 | Medical Device Services
Elevate your Quality Assurance and Regulatory Affairs with our help Technical Documentation Management Compiling, reviewing, and updating technical files for medical devices, medical device software, and in vitro diagnostic devices to ensure full regulatory...
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...
