QM-Handbook
Templates for SOPs
Basic MDR Documents and Guidelines
Finished Documents
Business- & Certification Strategies
Definition of Milestones
Fund Raising and Venture Capital Strategies
- Business Plan and Pitch Paper with incorporated Certification Strategy and Milestones
For:
CE-Marking
MDR-Approval
Post-Market Surveillance
Available in different Document-Readiness-Levels (DLR):
Templates (DLR: 10%)
Basic Documents (DLR: 70%)
Finished Documents (DLR: 95%-100%)
Tools and Instruments:
Auditing
Hands-on
Coaching
Training-Quizzes and Questionnaires
Usability File
Plan
Report
Usability Pre-Asessment
Usability Testing Protocol
Usability Set-up Definition
Environment & User Research
Planning of Usability Studies
Formative Tests
Summative Tests
For:
CE-Marking
MDR-Approval
Post-Market Surveillance
Available in different Document-Readiness-Levels (DLR):
Templates (DLR: 10%)
Basic Documents (DLR: 70%)
Finished Documents (DLR: 95%-100%)
Tools and Instruments:
Auditing
Hands-on
Coaching
Training-Quizzes and Questionnaires

Risk Management File
Plan
Report
FMEA
PHA
Assisting your Risk Management Team
For:
CE-Marking
MDR-Approval
Post-Market Surveillance
Available in different Document-Readiness-Levels (DLR):
Templates (DLR: 10%)
Basic Documents (DLR: 70%)
Finished Documents (DLR: 95%-100%)
Tools and Instruments:
Auditing
Hands-on
Coaching
Training-Quizzes and Questionnaires
Types:
Products
Processes
Software (IEC 62304)
Modern Concepts
New Technologies (POC)
For:
CE-Marking
MDR-Approval
Post-Market Surveillance
Available in different Document-Readiness-Levels (DLR):
Templates (DLR: 10%)
Basic Documents (DLR: 70%)
Finished Documents (DLR: 95%-100%)
Tools and Instruments:
Auditing
Hands-on
Coaching
Training-Quizzes and Questionnaires
Types:
Single arm
Two-sample parallel
Two-sample crossover
Testing Claims:
Equality
Safety
Noninferiority
Equivalence
Superiority
Stages:
Exploratory or Feasibility Study
Pivotal Study
Post-Market Study
For:
CE-Marking
MDR-Approval
Post-Market Surveillance
Available in different Document-Readiness-Levels (DRL):
- Templates (DRL: 10%)
- Basic Documents (DRL: 70%)
- Finished Documents (DRL: 95%-100%)
Tools and Instruments:
- Auditing
- Hands-on
- Coaching
- Training-Quizzes and Questionnaires
For:
New Products
Update of Existing Products
Modern Concepts
Future Technologies
Legacy Devices
Available in different Document-Readiness-Levels (DRL):
Templates (DRL: 10%)
Basic Documents (DRL: 70%)
Finished Documents (DRL: 95%-100%)
Tools and Instruments:
- Auditing
- Hands-on
- Coaching
- Training-Quizzes and Questionnaires