risk or benefit?


The digital transformation now influences virtually every area of our daily lives – and this also includes our health. In this context, mHealth (mobile health) apps now have an important role to play. Based on scientific research, these mHealth apps are applications that are intended to have a positive, long-term influence on our physical, mental and social well-being.

It is estimated that the number of health apps available will soon pass the 400,000 mark. The reasons for this burgeoning trend are not hard to find: almost everyone now owns a smartphone or tablet PC, and mHealth is an area that has the potential to improve the quality and effectiveness of our individual lifestyles, and to revolutionise the field of healthcare. However, many people are unaware that using some of these apps involves substantial risks and dangers – not least because of a lack of quality and validation standards. Apps in this category are known as medical apps. These are applications that are specifically designed to prevent, diagnose and treat illnesses or injuries. They are classified as medical devices and are therefore subject to strict regulatory requirements.

An app is considered to be a medical device if it is covered by the definitions of such devices given in the new European MEDICAL DEVICE REGULATION (MDR) 2017/745 of 5 April 2017. These definitions are typically generic to ensure that they cover many different products.

The decision as to whether an app is a medical device and therefore has certain responsibilities as regards the safety of the software is made by the app developer. This distinction – medical device or not – is specified by the developer in the intended purpose defined for the app. Previously, app developers were able to bypass the strict legal requirements relating to the safety and efficacy of medical devices easily, simply by describing their product as merely a health or fitness app. To close this legal loophole, the FDA published a document (‘Mobile Medical Application – Guidance for Industry and Food and Drug Administration Staff’) in 2013 that explains exactly which apps must now be classified as medical apps.

In Europe, a new Medical Device Regulation (MDR 2017/745) was adopted in April 2017 with the aim of improving public safety and health. Despite all of the above, it is not a trivial matter to determine whether or not an app is actually a medical device. Accordingly, we are happy to draw on our 20 years of experience in regulated environments to help you to resolve issues related to this critical legal requirement.


  • Software as a medical device:
    • Guidance for answering the question: is your app a medical device?
    • Guidance for classifying your medical app in the correct risk class.
  • Medical app validation
  • Advice on Unique Device Identification (UDI) systems (also mandatory for medical apps from April 2017)
  • Compliance awareness workshops
  • Evaluation of your existing Quality Management system or setup of a new QMS
  • Update from ICH 9001 to ISO 14971
  • Preparation and review of standard operating procedures (SOPs)


Make use of our experience and industry expertise as medical app compliance specialists!

  • 20 years of expertise in GxP compliance
  • A wealth of expertise in regulatory requirements
  • Broad-based experience with a very wide range of IT systems
  • Integrative approach adopted for existing QM systems
  • High level of knowledge transfer
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0

Matthias Bothe, DHC GmbH
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7

Carsten Buri, DHC AG
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Learn more about our consulting services for GxP Compliance!



16. April
Webinar (in German)

VxP, the cloud-based Validation Platform for the Life Sciences

With VxP, DHC offers a cloud-based validation platform to accelerate validation processes and digitalise documentation.

22. April
SAP QM Online Info Day

Boost your Quality Management

On the topic of “Integrated QMS”, the SAP partners, DHC and SSE, will present current concepts and use cases at the online info day on 28 April 2021.

23. April
Webinar (in German)

SAP S/4HANA Deployment Options for Life Sciences (Cloud vs. On-Premise)

This webinar looks at the different SAP S/4HANA deployment options from the perspective of regulatory requirements in life sciences.

28. April
Online Info Day

Digitalisation of the computerised systems validation (CSV)

In this CSV online info day, we explain the characteristics, possibilities and challenges of digital validation.

30. April
Webinar (in German)

Using SAP Fiori Apps for QM in ECC 6.0

This webinar will introduce SAP Fiori Apps for QM and how they can be integrated into an SAP system that has not yet been converted to S/4HANA.

06. Mai
Webinar (in German)

UDI: Implementing global requirements with the right strategy and software

Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of projektraum36

07. Mai
Webinar (in German)

IT Compliance Framework – Your key to digital validation

Presentation of the structure and essential contents of the IT Compliance Framework and description of the possibilities of use.

11. Juni
Webinar (in German)

QM implementation as part of the digitalisation strategy at Medartis AG

Learn how we have optimised important core QM processes in the course of digitising production and introduced them on the basis of SAP QM.

25. Juni
German Webinar

Which QM functionalities does S/4HANA 2020 offer and which not?

Free webinar about the standardized DHC method for software evaluation using the example of QM in S/4HANA.

09. Juli
Webinar (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

09. November
Life Online Training

SAP: Validation and GMP Compliance (Live Online Training der ECA Academy)

Online training with speakers from DHC GmbH, organised by Concept Heidelberg on behalf of the ECA Academy,


Our webinars are provided as a free service for DHC customers and potential customers.