Wellspect’s clinical study program is developed and conducted together with leading clinicians in the field. All our studies are conducted according to Good Clinical Practice (GCP), the Declaration of Helsinki, Wellspect HealthCare Standard Operating Procedures (SOP) and applicable rules and regulations. Compliance with the international standard ISO 14155 on clinical investigations of medical devices for human subjects.
Post-market product surveillance is performed to gain further knowledge about safety and performance of our products in clinical use after release on the market. Monitoring products in this phase may include clinical research, literature reviews or surveys.
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