Certification Levels and Requirements

Below are the 3 levels of certifications: GREEN, PRO, and MASTER. 
Terminologies are explained further down. 
By clicking on the hyperlink, you will be redirected to the corresponding pages, e.g. the Green Certification Quiz (GCQ).

GREEN

Beginner level;

Mandatory to transit to Pro level within 3 months.

PRO

Most prosthetists should be at this level;
Allowed to fit patient independently;

Valid for 1 year.

MASTER

Trainer level;
Allowed to train other prosthetists;
Valid for 1 year.


GREEN

  1. Attend the Beginner Training (BT, G1) ;

  2. Watch or do a Guided Patient Fitting (GPF), with the supervision of a MASTER trainer;

  3. Practice  filling in the form Patient Fitting Record (PFR, G2);

  4. Pass the Green Certificaiton Quiz (GCQ, G3);

  5. Tell us (GREEN request form, G4) .
PRO
  1. Do an Indepedent Patient Fitting and send in a PFR form (P1);
  2. Via the IPF webpage, submit the pictures and videos required for Indepdent Patient Fitting (IPF, P2). You can upload videos directly or provide Youtube/Vimeo links to the videos that you have uploaded there (make sure the videos are "unlisted");
  3. Request PRO ceritifcate using P3.
MASTER
  1. Attend the Master Training (MT, M1);
  2. Finish two more IPFs and submit the PFRs (2x M2) for these two fittings, and submit the pictures and videos for these two IPFs (2x M3);
  3. Perform and record the Beginner Training for Master Qualification Practice (MQP), and upload the video to Youtube or Vimeo, send the link using MQP form (M4);
  4. Pass the Master Certification Quiz (MCQ, M5);
  5. Request MASTER certificate using the button M6.
En tant que MASTER, comment certifier les autres ?

GREEN

  1. Request portal accounts for the trainees 2 workdays before the Beginner Training, using the helpdesk (type de ticket: Portal Account);
  2. Perform the training and GPF, and let the trainee practice PFR;
  3. Let the trainee finish the GCQ avant la fin de la formation;
  4. Demandez au stagiaire de demander un certificat GREEN en utilisant le bouton "Tell Us" . 

PRO

  1. Laissez le stagiaire effectuer un IPF. Et pour terminer le PFE, vous avez deux options :
    1. On site: Observe the trainee's IPF and the MASTER performs the exam using the form PFE;
    2. À distance : laissez le stagiaire effectuer l'IPF et télécharger des photos et des vidéos à l'aide du formulaire IPF. Une fois les fichiers téléchargés, notre équipe de certification recevra un ticket et vous donnera la permission de voir les photos/vidéos IPF (en vous ajoutant en tant que suiveur du ticket helpdesk), puis vous pourrez vérifier les fichiers et effectuer l'examen en utilisant le formulaire PFE.
  2. REMEMBER: It is the MASTER who is allowed to do PFE, not the trainee.
  3. Après l'IPF/PFE, demandez au stagiaire de demander un certificat PRO​ en utilisant le bouton en bas de la colonne PRO.

Comment le certificat sera-t-il délivré ?

  1. Notre équipe de certification recevra un ticket d'assistance si quelqu'un demande un certificat. Notre équipe de certification ajoutera le formateur en tant que suiveur du ticket afin que vous puissiez voir la progression et le certificat si nécessaire.
  2. Pour délivrer le certificat, vous avez deux options :
    1. Reboocon Bionics délivre le certificat : après réception de la demande de certificat, notre équipe de certification vérifiera les preuves/enregistrements (par exemple, GCQ, PFR ou PFE). Si tout est complet, Reboocon Bionics délivre directement le certificat. En tant que suiveur du ticket, le MASTER/Trainer reçoit également les e-mails contenant le certificat.
    2. Le distributeur de Reboocon Bionics délivre le certificat : après réception de la demande de certificat, notre équipe de certification vérifiera les preuves/enregistrements (par exemple, GCQ, PFR ou PFE). 
      1. ​Si les dossiers sont complets, nous informerons le formateur pour délivrer le certificat. Le formateur doit délivrer le certificat en répondant au ticket de demande de certification, avec le certificat en pièce jointe au format PDF. Ensuite, Reboocon Bionics, le stagiaire et le formateur auront tous un record.
      2. Si les enregistrements sont incomplets, nous informerons le formateur et le stagiaire d'ajouter les enregistrements manquants, puis nous revérifierons.
  3. Toutes les demandes de certification sont traitées comme des tickets Helpdesk. Toutes les communications se font par e-mails. En répondant au mail du ticket, nous nous tenons mutuellement informés.

Recertification will mostly be done remotely, in a format of webinar plus a quiz.
The goal of recertification is 

  1. to refresh the knowledge, and 
  2. to update the certificate holders about product changes and planned changes.

Sometimes, recertification can also take a physical format, where annual gathering of certificate holders will be held and on-site interaction will be possible.

All the hyperlinks on this page either bring you to a SURVEY form or a HELPDESK form.

  • SURVEY: We use survey forms mainly for record keeping (e.g. PFR), and quizzes or exams (e.g. GCQ, MCQ, or PFE, MQE). Whenever you fill one, a record is generated in our system. We don't get a notification, if you want us to know, please use one of the other buttons to file a helpdesk ticket.
  • HELPDESK: The form will lead to a helpdesk ticket. For example, IPF, MQP, "Tell us", "Request PRO", and "Request MASTER" will make a helpdesk ticket, and you will receive automatic confirmation emails. Our customer support team or certification team will get notified and reach out to you. 

During the Begineer Training (BT), the following knowledge are provided:

  1. Introduction to the Company Reboocon Bionics B.V.
  2. Overview of the Product Intuy Knee
  3. Service and Warranty
  4. Scope of Delivery and Component Selection
  5. Product Modifications and News
  6. Human Gait and Biomechanics
  7. Alignment
  8. Training of Movements
  9. Device Signals and Battery charging
  10. Intuy App – the Mobile app for Intuy Knee
  11. PMS and Vigilance
  12. Training Program and Certification

The Master Training (MT) is focusing on 

  1. in-depth knowlegde of the device, such as troubleshooting techniques,
  2. providing customer support,
  3. and sales-oriented knowledge of the Product.

According to the latest regulation and international standard on Quality Mangement System (e.g. ISO 13485, cl. 7.5.3): 

The organization shall document requirements for medical device installation and acceptance criteria for verification of installation, as appropriate.
If the agreed customer requirements allow installation of the medical device to be performed by an external party other than the organization or its supplier, the organization shall provide documented requirements for medical device installation and verification of installation.
Records of medical device installation and verification of installation performed by the organization or its supplier shall be maintained.

when a patient is fitted with our device, installation records and verification records need to be kept.
Therefore we made this Patient Fitting Record (PFR) form for convinience. It is an online form. When the patient fitting is done and patient taining is completed, please make sure that this form is completed and sent to us. 

The PFR also serves as a STEP-BY-STEP guide of patient fittings to the prosthetists. Prosthetist should use it and tick all the boxes when fitting Intuy Knee.

Right after the Beginner Training (BT), we will let the prosthetists get hand-on experiences with the device and mobile app. We guide the prosthetist (trainee) thru the patient fitting, step by step to ensure good understanding of the device and the app.

After a prosthetist has obtained the GREEN certificate, he/she is allowed to fit patient indepependently within 3 months. To get to PRO level, the prosthetist is required is record his first Independent Patient Fitting (IPF) according to the requirement specificed in this page

To get to MASTER level from PRO level, the prosthetist is required to have completed successfully at least three IPFs, so meaning, two extra IPFs.

IPF video recordings are sent to Reboocon Bionics using the online form at the bottom of the IPF page. Videos are then examined by the team of Reboocon Bionics according to a unified scoring system (the PFE). The prosthetist is informed within 1 week whether he has passed the Patient Fitting Exam (PFE). Alternatively, this PFE can take place live, with Reboocon Bionics's team on site.

A MASTER certificate holder (outside of Reboocon Bionics's team) can perform training and certification as well, he/she can use the PFE to evaluate the IPF of trainees. REMEMBER: It is the MASTER who is allowed to do PFE, not the trainee.

A Green Certification Quiz (GCQ) consists of about 30 questions. The questions are based on the contents of Beginner Trainning. A candidated is required to answer at least 90% of the questions correctly to pass the quiz. After attending the Beginner Training(BT) and passing the GCQ, the candidated is granted with Green Ceritificate.

The Master Certification Quiz(MCQ) is based on the contents of the Master Training (MT) and the 3 patient fitting experiences of the Master candidate. More in-depth knowledge is checked.

A Master candidate is required to provide a simulated training to others (record a training presentation). All the key information that covered during the Beginner Training (BT) must be covered. 

The presentation can be examined by a team of Reboocon Bionics B.V. on site or the recording of the presentation can be examined by Reboocon Bionics B.V. according to a unified scoring system. This is so called Master Qualification Exam (MQE).