ISO 14155 - GOOD CLINICAL PRACTICES
What is ISO 14155?
The International Organization for Standardization (ISO) publishes the ISO standard for Good clinical practices (GCP) for the design, conduct, recording, and reporting of clinical studies with medical devices.
Conducting your clinical studies according to GCP is important not only to collect good quality data under ethical conditions but also for regulatory compliance in the European Union (EU) and rest of the world.
The EU Medical Devices Regulation (MDR) 2017/745 requires clinical investigations to be conducted according to GCP and directly references the ISO14155 standard. The US Food and Drug Administration (FDA) accepts clinical data collected outside the US for market applications under the condition that GCP has been followed. FDA recognizes the ISO 14155 standard for medical device trials. Other regions similarly recognize the GCP standard.
Benefits of ISO 14155 Certification
Who can be certified ISO 14155 Certification?
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Document required for ISO 14155 Certification
The extent of Documented Information differs as per:
Role of Shamkris and Process of ISO 14155 Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below: