Certificates
ISO 13485:2016
Breast
Breast
Abdominal wall
Thoracic wall
Lymph nodes
Thyroid
Parotis
Muscles
Liver
Female internal reproductive organs
Uterus
Ovary
Retroperitoneal lymph nodes
MDD93/42/EEC
FDA approvals
While Bioncise succesfully applied for MDR 2017, the certification is still ongoing due to incapacity of the Notified Body to issue the certificates. Until certification is published Bioncise benefits from the transitional provisions for certain medical devices that apply to the Spirotome and Corticore lines of products. More info in the "Dedrogation Publication".
MDR2017
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