ISO 14155ISO 14155 Clinical investigation of medical devices for human subjects : General requirements
ISO 14155-1 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:
- protect human subjects;
- ensure the scientific conduct of the clinical investigation;
- assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
The following milestones will be a part of the ISO 14155 Certification / ISO 14155 Consultancy project
- Writing documents wrt Clinical Studies and in line with ISO 14155
- Writing Standard Operating Procedures for Planning and conducting Clinical Studies as per ISO 14155
- Consultancy on ISO 14155 Documentation, reporting and monitoring of Clinical studies as per ISO 14155
- Writing responsibilities and authorities of key personnel
- Identification of Legal requirements for Clinical study and documenting as required by ISO 14155
- Training on ISO 14155 Standard
- Conducting Internal audit based on ISO 14155
- Kick-start Management Review meetings
Looking for ISO 14155 Consultant, ISO 14155 Certification, ISO 14155 Certificate, ISO 14155 Documents, ISO 14155 Consultancy, ISO 14155 Clinical Investigation Located in Singapore, Maldives, Dubai, Abudhabi, Sharjah, Doha, Bahrain, Kuwait, Cameroon, Nairobi, Tripoli, Tunisia drop an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it and we will revert within 2 working days.
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