Key Aspects of Our Biological Evaluation Services: Biological Evaluation Plan (BEP) We begin with the creation of a structured BEP outlining the assessment strategy for your device. This includes identification of potential biological hazards, applicable endpoints,...
Apr 2025 2 Biological Evaluation Reports (BER) under the EU MDR Medical Device Services | 2 min readAt MDS Finland, we provide comprehensive Biological Evaluation Reports (BER) and supporting documentation in accordance with Annex I and Annex II of the EU Medical...
KEY ASPECTS OF OUR GLP STUDY SERVICES Compliance with GLP Standards We ensure that all aspects of our GLP studies adhere to international Good Laboratory Practices, including proper study planning, execution, monitoring, recording, archiving, and reporting. Study...
Key Aspects of Our Clinical Trial Auditing Services Clinical Trial Auditing We conduct thorough audits of clinical trials to assess compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Our auditing covers all stages of...
Key Aspects of Our CRA and Monitoring Services Research Protocol Development Our CRA team is actively involved in developing comprehensive research protocols that outline objectives, design, methodology, statistical considerations, and the overall structure of a...
