by adminReaktio | Feb 13, 2025 | Medical Device Services
Understanding the Biological Evaluation Report (BER) Ensuring the biological safety of a medical device is a crucial aspect of meeting the European Medical Device Regulation (MDR, EU 2017/745) requirements. At the heart of this process is the Biological Evaluation...
by adminReaktio | Feb 6, 2025 | Medical Device Services
Understanding the Biological Evaluation Plan (BEP) Ensuring the biological safety of a medical device is a fundamental requirement under the European Medical Device Regulation (MDR, EU 2017/745). A core component of this process is the Biological Evaluation Plan...
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...
