by adminReaktio | Nov 7, 2024 | Medical Device Services
Our Medical Device and Quality Management Training Covers QMS Fundamentals and Implementation We provide structured training on the principles, setup, and ongoing maintenance of a compliant Quality Management System (QMS) based on ISO 13485. Topics include QMS...
by adminReaktio | Nov 7, 2024 | Medical Device Services
How our ISO 10993 Biocompatibility Testing Services compliment your Biological Evaluation Biological Evaluation Plan (BEP) We begin by developing a Biological Evaluation Plan (BEP) which reviews the device and its materials, identifies potential biological risks, and...
by adminReaktio | Nov 7, 2024 | Medical Device Services
Ensure Electrical Safety with IEC 60601 Testing Services Foundational Standard IEC 60601-1 Compliance The IEC 60601-1 standard is the cornerstone of the series, setting the general requirements for basic electrical safety and essential performance. We provide thorough...
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...
