• 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

CONTACT US!

  • 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

CONTACT US!

  • 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

CONTACT US!

 
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
CONTACT US!