The 5 steps to place your mobile medical app on the market including CE-mark. Learn to decide whether it is a medical device, learn to know the European regulations Medical Device Directive respectively Medical Device Regulation MDR and standards such as IEC 62304, ISO 14971 and IEC 62366.

1. Medical Apps
Develop compliant with laws & standards
Document efficiently
Safely pass audits
Prof. Dr. Christian Johner

2. You learn the five steps and learn to know
the …
§ regulations (e.g. laws) to comply with,
§ documents you have to write / compile,
§ mistakes you want to avoid,
in order to place your medical app on the
market.

3. Step 1
Evaluate whether you app is a
medical device at all

4. MedicalDevice NoMedicalDevice
For diagnostic purposes For documentation only
For therapeutic purposes For education/training only
For monitoring e.g. of vital parameters Not specifically for healthcare
MedicalDevice NoMedicalDevice
Calculates drug dose Captures data for a clinical study
Controls a diagnostic or therapeutic device Is a digital version of a book
Shows radiology images Digital magnifying (general scope)
Visualizes data for ICU monitor Game for health education
Medical Device: Yes or No?
Examples

5. Unsecure whether your app is a medical device?
Just ask us!
www.johner-institut.de/kontakt

6. Step 2
Understand the regulations
(if your app is a medical device only)

7. Medical Device Directivewww
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:HTML
The Medical Device Directives (MDD, 93/42/EWG)
respectively MER and thereby the nationals laws (e.g.
MPG) require:
MDD,
MDR
1. Risk Management
2. Software-Lifecycle processes,
Verification and Validation3. Usability

8. Taketheserequirements
seriously!

9. Authorities will assume compliance with these “essential
requirements” if you stick to the respective standards
MDD,
MDR
ISO 14971
Risk Management
Software-Lifecycle Processes,
Verification and Validation
IEC 62304
Usability
IEC 62366

10. IEC62304requiresaQualityManagementSystemitself:
MDD
ISO14971
RiskManagement
Software-LifecycleProcesses,
VerificationandValidation
IEC62304
Usability
IEC62366
QM-System
ISO13485

12. Step 3
Establish a QM-System
(not trivial)

13. Describe…
§ your organization, quality politics and quality gaols
§ how you control your documents
§ how you manage your (Human) Resources
§ your processes e.g.:
- (Software-)Development and Maintenance
- Hotline, Support
- Risk Management
§ how you improve your QM-System (measurement,
internal audits, management reviews etc.)

14. As a result you will have
§SOPs (process descriptions)
§Work Instructions
§Templates, Forms
§Check lists
As word documents, PDFs or web pages

15. § Do you have any questions? Do you need support?
§ Are you looking for example documents or templates you
just have to adapt?
§ Do you want to be sure that you will pass your next
audit?
Then ask us!
www.johner-institut.de/kontakt

16. Step4
WriteandcompileyourTechnical
Documentation
(according to your QM-System)

17. Usability
Software-Development
ClinicalEvaluation
These are the files you have to compile

18. Usability
Software-Development
ClinicalEvaluation
Example: Software-Development
§ Software Development Plan
§ Software Requirements
§ Software Architecture
§ Code, Code Reviews
§ Static Code Analysis
§ Unit, Integration and System
Tests
§ Software Validation
§ Software Release

19. Step 5
Declare conformity of your product and
submit Technical Documentation to
your notified body
(depends on class of your product)

20. § You(!) declare – following a
conformity assessment procedure –
the conformity of your medical
device with the essential
requirements according to MDD.
§ Depending on the class (I, IIa, IIb, III
as defined by MDD) you have to
submit the Technical Documentation
to your notified body (e.g. TÜV, bsi,
mdc).
§ That’s it!

21. Frequent Traps

22. As we are (lead) auditors, consultants and developers ourselves
we know the challenges app developers are facing frequently:
§ Risk management file is incomplete or incorrect. Terms as
hazard and hazardous situation are mistaken.
§ Principals of a professional software engineering are ignored –
in particular during maintenance
§ The QM-System does not cover all requirements as described in
ISO 13485
§ The company does not follow the own “rules” according to QM-
System) appropriately
§ Documents are not up-to-date and or not approved

23. § Write and review your documents
§ Establish your lean QM-System
§ Prepare you for audit
§ Answer your questions
We love to support you!
www.johner-institut.de/kontakt
We help you to pass your audit – safely, fast and cost
efficient – and to develop safe and successful apps.

24. Prof. Dr. Christian Johner
All our several hunderd customers passed audit
successfully (with the first attempt)
„Das Resumee der Auditoren war, dass wir in Zukunft mit unserem eingeschlagenen Weg
über ein sehr schönes, kleines, nicht teures QA-System verfügen werden, das auch genau zu
uns passt. Das hat uns sehr gefreut, und ich möchte Ihnen nochmals danken, denn ohne die
Workshops mit Ihnen wäre das Ergebnis nicht so gut ausgefallen.“
(Regina Preysing, Qualitätsmanagerin BodyTel)
„Mit der praxisnahen Hilfe von Professor Johner und seinem Team
konnten wir in wenigen Monaten ein ‚lebbares' QM-System für unser
Unternehmen etablieren und erfolgreich nach ISO 13485 zertifizieren.
Die angenehme Zusammenarbeit und die Tatsache, dass wir das
Projekt in der geplanten Zeit und den geplanten Kosten abschließen
konnten, schätzen wir sehr.“
(Dominik Blei, Entwicklungsleiter
Gesellschaft für Patientenhilfe)

25. Some of your customers
(from global corporation to
4 person startup)

26. Johner Institut GmbH
Villa Rheinburg
Reichenaustr. 1
78467 Konstanz
+49 (7531) 94500 20
mail@johner-institut.de
www.johner-institut.de/kontakt
Complimentary E-Book:
www.johner-institut.de
Contact us!