Quality Commitment and ISO 13485 Certification for Our Medical Devices

At APIS Technologies, we specialize in the design, manufacturing, and distribution of innovative medical devices that meet the strictest quality and safety requirements.

Our processes and all our activities are EN ISO 13485:2021 certified, ensuring the compliance of our implantable medical devices with current international standards. This certification attests to our commitment to providing safe and effective surgical implants for the treatment of urinary incontinence and pelvic organ prolapse.

We apply a rigorous manufacturing process to ensure the reliability of our ISO-certified medical devices. Our commitment is based on several pillars:

Regulatory Rigor: As a medical device manufacturer, we adhere to a strict legislative framework, guaranteeing the safety and performance of our products, including our suburethral slings, transobturator slings, and other urogynecological medical devices.

Quality of materials and components: Our surgical implants are designed with high-quality materials, ensuring biocompatibility and clinical efficacy.

Strict controls at every stage of manufacturing: From supplier selection to production, we apply rigorous control procedures to guarantee the safety of our medical devices for incontinence and prolapse treatment.

Robust clinical validation: Our solutions are tested and validated to ensure optimal effectiveness in the treatment of female urinary incontinence, male urinary incontinence, and pelvic organ prolapse.

Trusted business partnerships: We collaborate with healthcare professionals and reliable distributors to ensure the availability and traceability of our implantable medical devices.