RAMPmedical Demonstrates Compliance with ISO 13485

Updated: Oct 2, 2019

Press release - 20190930


The digital health software provider RAMPmedical, startup from Berlin and synonym for hope for diabetes patients for better care and for hospitals to cope with unprofitable diabetes departments, demonstrates compliance with ISO 13485.

As low funded high-tech startup from Berlin and winner of Startupbootcamp, the EIT Health Award allowed the team of RAMPmedical to achieve compliance with the high ISO 13485 standard, registering for class 1 of the current medical device regulation.


The problem

Start-ups, doctors, politicians and innovation departments of medtech and pharmaceutical companies have been driving digital health solutions towards an improvement of health and well-being – creating hope for 420 million people that suffer from a severe chronic disease: diabetes mellitus (World Health Organization – WHO 2016). Unfortunately, hype and misplaced incentives for players in the field are making the knowledge about its maturity and applicability non-transparent.

The German drug commission, the WHO and the RAMPmedical study (among others) have found that in up to 29% of the cases diabetes patients receive therapies that are contraindicated for the particular case and therefore put the person at high fatal risk. Most of the prescribed drugs are neither the cheapest, the most efficient, the best tolerated nor the safest. The reasons are the non-transparency of information, like research results, and the challenge to adapt long patient histories to it.


The solution

RAMPmedical matches the complex patient data of each individual type 2 diabetes patient with potential therapies. It aims towards two goals: firstly, avoid dangerous treatments that are often overseen by doctors due to the complexity of the disease and the patient history; secondly, identify the most efficient treatment for the particular case.


Past events

RAMPmedical released in June 2019 its first version of the evidence-based decision support software for doctors that treat diabetes patients

In a first study last year, doctors performed much better, using the prototype of the software than doctors that only used their usual means – better than any specialist ever performed.


Contact

Helene Schönewolf, CEO, Helene.schoenewolf@rampmedical.com, +49 172 9093 359

Video from EIT Health about RAMPmedical:

https://www.youtube.com/watch?v=7SUNw33Y4KM&t=3s

RAMPmedical

Henisaja GmbH

 

Kastanienallee 61

10119 Berlin

​info@rampmedical.com

Chief Executive Officer:  Helene Schönewolf

+49 (0) 30 31 98 08 52​

Registered at the local court Berlin Charlottenburg HRB 167143 B

VAT: DE299921795

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