IVDR Review

Expert support adapting SOPs to the IVDR.

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  • Complete service that will ensure your SOPs comply to the IVDR and standards you require.
  •  Checking bilingual documents in German and English.
  • IVDR review report in an Excel document with clear visuals and compliance markers to track and review updates.
  • Regulatory and quality management experts that will check the full scope of respective requirements.
  • Experienced knowledge and latest insights into requirements for IVDR, ISO GCP, ISO 14971, PMS, QMS, ISO 13485, MDSAP, UDI, and more.

Description

Our regulatory and quality management experts will review your standard operating procedures (SOPs) to make sure they comply to the new in-vitro Diagnostics Medical Devices Regulation (EU) 2017/746 (IVDR) and any related standards or regulation. As SOPs often involve multiple people and departments it can be helpful to bring in a fresh pair of eyes to review all requirements from start to finish. This service will analyse every aspect of an SOP in relation to the IVDR, wider regulation and the standards you require – spanning departments, standards, drafts and documents that can include Good study practice (ISO 20916), Risk Management (ISO 14971), Post-Market Surveillance (PMS), Quality Management Systems (QMS, ISO 13485, MDSAP), and Unique Device Identifier (UDI), and more.

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