Certified medical product

Certified medical product

The saccadic training has been a medical product since July 2020. Unfortunately only six of the original 15 exercises could be certified. If you want to use all 15 exercises, you can use the new app Oculy:

What does that mean?

  • This product is approved according to current legislation as a certified medical product.
  • The software is used for the therapy of limitations that affect the visual field. The loss of visual field is to be compensated by the increased use of saccades.
  • The product was developed on the basis of interviews with patients and health professionals (physicians, neuropsychologists, orthoptists and occupational therapists).
  • On the basis of these interviews, it was precisely defined which requirements the product must meet.
  • Then the product was developed according to a predefined software development plan.
  • In addition, the software was tested for various risks: Every person can use the software without hesitation as long as he/she does not have an acute eye disease (e.g. inflammation) or suffers from photosensitive evocative epilepsy
  • Risks and the entire product are regularly checked for errors according to a predefined test scenario.
  • The product was evaluated clinically: It was found that it is a comparable product in the field of compensatory eye training and it is not necessary to investigate the product with an own study as it is based on a well investigated principle.




Partner

BFH

Johner



Declaration of conformity

KONFORMITÄTSERKLÄRUNG / DECLARATION DE CONFORMITE
DECLARATION OF CONFORMITY / DICHIARAZIONE DI CONFORMITA
Name und Adresse der Firma
Nom et adresse de l’entreprise
Nome eindirizzo della ditta
Name andaddress of the firm
GURTNER IT SOLUTIONS...................................................
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Wir erklären in alleiniger Verantwortung, dass / Nous déclarons sous notre propre responsabilité que /
Dichiariamo sotto nostra responsabilità che / W e declare underour soleresponsibility that
das Medizinprodukt
le dispositif médical
the medical device
il dispositivo medico
Saccadic training.....................................................................
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Bezeichnung, Typ oderModell, Chargen- oder Seriennummer, ev. Herkunft und St üc kzahl
Nom, type ou modèle, numéro de lot ou série, év. source et nombre d'exemplaires
Nome, tipoo modello, numero di lotto o di serie, ev. fonte e numerodi esemplari
Name, type or model, batch or serial number, possibly sources and number of items
derKlasse /delaclasse /dellaclasse /of
class
Klasse 1.................................................................................
Nach Anhang IX
der Richtlinie 93/43/EWG / selon l'annexe IX

de la directive 93/42/CEE /
secondo l'allegato IX
delladirettiva93/24/CEE /accordingtoannex IX

of direct. 93/42/EEC
allen Anforderungen der Medizinprodukte-Richtlinie 93/42/EWG (od. 90/385/EWG) entspricht , die anwendbar sind
/ remplit toutes les exigences de la directive sur les dispositifs médicaux 93/42/CEE (ou 90/385/CEE) qui le
concernent /soddisfa tutte le disposizioni della direttiva 93/42/CEE (opure 90/385/CEE) che lo riguardano /
meets all the provisions of the directive 93/42/EEC (or 90/385/EEC) which apply to it.
Angewandte harmonisierte Normen, natio-
naleNormen oder andere normative Dok u-
mente
Normes harmonisée, normesnationales et
autres documents normatifs appliqués
Norme armonizzate o nazionali applicate,
altri documenti normativi applicati
Applied harmonised standards, national
standards or other normative documents
93/42/EWG inklusive 2007/47/EG..........................................
Angewandte Regeln: Regel 12 aus Anhang IX......................
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Konformitätsbewertungsverfahren
Procédure d’évaluation de la conformité
Procedimentodivalutazionedellaconformità
Conformity assessment procedure
...............................................................................................
Konformitätsbewertungsstelle (falls beigezogen)
Organeresp.
del'évaluat.delaconformité(siconsulté)
Organoincaric.dellavalutaz.della conform.(se consultato)
Notified Body (if consulted)
............................................................................
Bern, 7. Mai 2020................................................
Ort, Datum / Lieu, date / Luogo, data / Place, date
Beat Gurtner, Managing Director
Name und Funktion / Nom et fonction /
Nome e funzione / Name and function
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