Key Aspects of Our CRO Project Management Services Professional Clinical Research Associates (CRAs) Our team of professionally qualified CRAs manages the protocol design, study setup, and oversight of clinical trials, ensuring adherence to the highest standards....
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...
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...
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...
KEY ASPECTS OF EUROPEAN AUTHORIZED REPRESENTATIVE 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 Regulation (MDR)...
