ENDOMOBIL. WITH SAFETY!
We focus on safety when it comes to servicing and repair. Maximum patient protection is mandatory, which is why our innovative service operation is monitored in annual audits by MEDCERT – an independent medical testing company based in Hamburg who are used by the EU – and certified according to ISO 13485. With ambitious quality management and the implementation of all servicing, repair and hygiene standards in a way which consistently confirms with standards and legislation, we guarantee maximum patient safety and transparency.
Ihr Vertrauen in unsere Kompetenz ist unser Kapital.
ENDOMOBIL GmbH only uses certified replacement parts so that you can continue to use your endoscope. In this context, certified means that the replacement parts which are produced for us or purchased by us have been produced according to the manufacturer’s specification with the original dimensions. Here, we take dimensions, power safety and toxicological requirements into account.
Even when your endoscope is no longer an active “device” within the meaning of the German Act on Medical Devices, we take great care to ensure that the dimensions, functionalities etc. are not changed. As ENDOMOBIL GmbH does not sell any products for the endoscope, we do not need to display any declaration of conformity. As a certified company, MedCert in Hamburg has recorded and inspected our replacement parts supply. This includes the production and inspection of the supplied replacement parts.
SERVICE - HYGIENE
SERVICE - TECHNOLOGY
SERVICE - LAW
Hygiene
For us, the best service possible in terms of safety all starts with meticulous hygiene! The anti-static floor coverings in our workshops correspond to the latest internationally applicable cleaning and disinfection standards, just like both our cleaning and disinfection devices (RDG-Es).
Before the final shipping, every single instrument which is assembled here is washed and treated in our cleaning and disinfection devices (RDG-Es) – this can also be done with or without aldehydes, depending on customer wishes.
Technology
For us, the best possible service in terms of safety only works with the greatest level of quality management and expertise! Regular ISO certifications guarantee that we adhere to all the technical guidelines dictated by standards and legislation for every repair that we carry out. Each product is also tested for unrestricted function by further official certifying bodies as well as our technicians before being delivered with transport and electronics insurance.
Law
For us and our customers, the best possible service in terms of safety means legal protection – on one hand from the manufacturers Olympus, Pentax or Fujinon, on the other hand, from the patients that the devices will be used on after servicing, maintenance or repair! All questions and aspects in this regard are monitored for us by our appropriately specialised lawyers based in Hamburg.
We want to offer the maximum degree of safety.
MEDCERT
Every year, ENDOMOBIL is certified for ISO standard 13485 by the company MEDCERT. MEDCERT is a German society which specialises in the certification of products and quality management systems in the medical technology sector.
AMDSO
ENDOMOBIL is a member of the Association of Medical Device Service Organizations (AMDSO), an international society for improving the quality of servicing and repairs for reusable medical devices, and for improving the training of the specialist staff involved.