http://www.johner-institut.de The five to steps to develop and market your Medical App as a medical device compliant with European medical device regulations.

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. Medical Device: Yes or No?
Medical Device No Medical Device
For diagnostic purposes For documentation only
For therapeutic purposes For education/training only
For monitoring e.g. of vital parameters Not specifically for healthcare

5. Medical Device: Yes or No?
Medical Device No Medical Device
For diagnostic purposes For documentation only
For therapeutic purposes For education/training only
For monitoring e.g. of vital parameters Not specifically for healthcare
Examples
Medical Device No Medical Device
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

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

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

8. The Medical Device Directives (MDD, 93/42/EWG) and thereby
the nationals laws (e.g. MPG) require:
MDD

9. The Medical Device Directives (MDD, 93/42/EWG) and thereby
the nationals laws (e.g. MPG) require:
1. Risk Management
MDD

10. The Medical Device Directives (MDD, 93/42/EWG) and thereby
the nationals laws (e.g. MPG) require:
1. Risk Management
MDD
2. Software-Lifecycle processes,
Verification and Validation

11. The Medical Device Directives (MDD, 93/42/EWG) and thereby
the nationals laws (e.g. MPG) require:
1. Risk Management
MDD
2. Software-Lifecycle processes,
3. Usability Verification and Validation

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

13. Take these requirements
seriously!

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

15. IEC 62304 requires a Quality Management System itself:
ISO 14971
Risk Management
MDD
Software-Lifecycle Processes,
Verification and Validation
IEC 62304
Usability
IEC 62366

16. IEC 62304 requires a Quality Management System itself:
ISO 14971
Risk Management
MDD
Software-Lifecycle Processes,
Verification and Validation
IEC 62304
Usability
IEC 62366
QM-System
ISO 13485

17. Read these
standards!

18. Read these
standards!
✓ ISO 13485

19. Read these
standards!
✓ ISO 13485
✓ ISO 14971

20. Read these
standards!
✓ ISO 13485
✓ ISO 14971
✓ IEC 62304

21. Read these
standards!
✓ ISO 13485
✓ ISO 14971
✓ IEC 62304
✓ IEC 62366

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

23. Describe…

24. Describe…
▪ your organization, quality politics and quality gaols

25. Describe…
▪ your organization, quality politics and quality gaols
▪ how you control your documents

26. Describe…
▪ your organization, quality politics and quality gaols
▪ how you control your documents
▪ how you manage your (Human) Resources

27. Describe…
▪ your organization, quality politics and quality gaols
▪ how you control your documents
▪ how you manage your (Human) Resources
▪ your processes e.g.:

28. 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

29. 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

30. 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

31. 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.)

32. 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.)

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

34. ▪ 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?

35. ▪ 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

36. Step 4
Write and compile your Technical
Documentation
(according to your QM-System)

37. Risk Management
Usability
Software-Development
Clinical Evaluation
Other

38. Risk Management
Usability
Software-Development
Clinical Evaluation
Other
These are the files you have to compile

39. Risk Managmeent
Usability
Software-Development
Clinical Evaluation
Other

40. Risk Managmeent
Usability
Software-Development
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
Clinical Evaluation
Other

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

43. ▪ You(!) declare – following a
conformity assessment procedure –
the conformity of your medical
device with the essential
requirements according to MDD.

44. ▪ 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).

45. ▪ 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!

46. Frequent Traps

47. As we are (lead) auditors, consultants and developers ourselves
we know the challenges app developers are facing frequently:

48. 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.

49. 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

50. 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

51. 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

52. 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

53. We love to support you!

54. We love to support you!
▪Write and review your documents
▪ Establish your lean QM-System
▪ Prepare you for audit
▪ Answer your questions

55. We love to support you!
▪Write and review your documents
▪ Establish your lean QM-System
▪ Prepare you for audit
▪ Answer your questions
We help you to pass your audit – safely, fast and cost
efficient – and to develop safe and successful apps.

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

57. All our 70+ customers passed audit successfully
(with the first attempt)
Prof. Dr. Christian Johner

58. All our 70+ 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)
Prof. Dr. Christian Johner

59. All our 70+ 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)
Prof. Dr. Christian Johner

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

61. Johner Institut GmbH
Villa Rheinburg
Reichenaustr. 1
78467 Konstanz
!
+49 (700) 697 126 40
mail@johner-institut.de
www.johner-institut.de/kontakt

62. Johner Institut GmbH
Villa Rheinburg
Reichenaustr. 1
78467 Konstanz
!
+49 (700) 697 126 40
mail@johner-institut.de
www.johner-institut.de/kontakt
Complimentary E-Book:
www.johner-institut.de

63. Johner Institut GmbH
Villa Rheinburg
Reichenaustr. 1
78467 Konstanz
!
+49 (700) 697 126 40
mail@johner-institut.de
www.johner-institut.de/kontakt
Complimentary E-Book:
www.johner-institut.de
Contact us!