Surge-on Medical ensures our instruments are compliant with the required regulations for medical devices. All our instruments are envisioned as steerable, detachable, and cleanable to allow reusability and to improve patient safety and care.
We utilize ISO13485 certified manufacturers that follow strict norms to deliver high quality surgical instruments. The ArtSurge Knee boasts the CE mark for Class I medical devices. It’s been registered in the Netherlands under the MDD since May 2020, as well as the NIDS in South Korea.
Other lines of instruments are still in research and development and will be soon registered for their CE mark.
Post-Market Surveillance Material
To ensure Surge-on Medical keeps delivering high quality surgical instruments, we need to receive your valuable feedback. The following online forms are for the users (surgeons or distribution companies) of our surgical instruments. Please fill in the correct form according to your needs or purposes.
Form 1: Medical Device Reporting Form
In the event of a malfunction or adverse event please use this form. Developed for end users—such as surgeons, medical staff, cleaning and sterilization staff, nurses, and distribution companies.
Note: If you want to return the instrument to Surge-on Medical for inspection you must also submit a Decontamination Declaration (Form 2).
Form 2: Decontamination Declaration
Complete before returning any instrument to Surge-on Medical. This form this to be completed by end users—surgeons, medical staff, cleaning and sterilization staff, nurses, or distribution companies.
Form 3: Post-Market Surveillance Form (Surgeons and Nurses)
Complete this form after the first use of a purchased instrument or after regular usage. You will receive a reminder from a representative of Surge-on Medical to submit your form along with the information to access it.
Form 4: Post-Market Surveillance Form (CSD or Cleaning Staff)
Complete this form after the first uses of a purchased instrument and regularly throughout its usage. You will receive a reminder from a representative of Surge-on Medical to submit your form along with the information to access this form.