Inserts or leaflets are typically for an at-home diagnostic, drug delivery, pharmaceutical, or combination device, and can be communicated in 5-10 steps.
MedTech Manual Packages
Offering fixed prices for standardized manuals streamlines the proposal and delivery process
1 page insert – delivered in 20 days*
What’s included
check_circleSingle page (double sided)
check_circleApplied Customer Branding
check_circle5-10 illustrations
check_circle1 iteration per Usability Evaluation
check_circleCopy (300 words)
check_circleFDA : 21 CFR 801.5 – Medical Devices; Adequate Directions for Use
check_circleFDA: ‘Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers’,
check_circleIEC/IEEE: 82079-1:2019 for Information for Use
check_circleIEC: 60601-1 requirements for the labeling and the accompanying documents (IFU) of Medical Electrical Equipment
check_circleANSI/AAMI/IEC: 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
check_circleANSI: Z535.6 for Safety Messages
check_circleISO: 3864 international standards for safety symbols
PDF and source files included
$14K
*key assumptions:
- A uFMEA / critical task analysis / TUEA of the device exists
- CAD or a prototype of the device exists.
- Prompt, collated feedback will be returned at iteration milestones.
Standard IFU – delivered in 4 weeks*
Standard IFUs are typically for an at-home diagnostic, drug delivery, pharmaceutical, or combination device, and can be communicated in 10-30 steps.
What’s included
check_circle10 or less pages
check_circleApplied Customer Branding
check_circle10-30 illustrations
check_circle1 iteration per Usability Evaluation
check_circleCopy (3000 words)
check_circleFDA : 21 CFR 801.5 – Medical Devices; Adequate Directions for Use
check_circleFDA: ‘Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers’,
check_circleIEC/IEEE: 82079-1:2019 for Information for Use
check_circleIEC: 60601-1 requirements for the labeling and the accompanying documents (IFU) of Medical Electrical Equipment
check_circleANSI/AAMI/IEC: 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
check_circleANSI: Z535.6 for Safety Messages
check_circleISO: 3864 international standards for safety symbols
PDF and source files included
$34K
*key assumptions:
- A uFMEA / critical task analysis / TUEA of the device exists
- CAD or a prototype of the device exists.
- Prompt, collated feedback will be returned at iteration milestones.
Complex IFU – delivered in 6 weeks*
Complex IFUs are typically for an at-home diagnostic, drug delivery, pharmaceutical, or combination device, and can be communicated in 30-60 steps. There are often associated integrated User Interface instructions.
What’s included
check_circle10 -30 pages
check_circleApplied Customer Branding
check_circle30-60 illustrations
check_circle1 iteration per Usability Evaluation
check_circleCopy (10,000 words)
check_circleFDA : 21 CFR 801.5 – Medical Devices; Adequate Directions for Use
check_circleFDA: ‘Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers’,
check_circleIEC/IEEE: 82079-1:2019 for Information for Use
check_circleIEC: 60601-1 requirements for the labeling and the accompanying documents (IFU) of Medical Electrical Equipment
check_circleANSI/AAMI/IEC: 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
check_circleANSI: Z535.6 for Safety Messages
check_circleISO: 3864 international standards for safety symbols
PDF and source files included
$64K
*key assumptions:
- A uFMEA / critical task analysis / TUEA of the device exists
- CAD or a prototype of the device exists.
- Prompt, collated feedback will be returned at iteration milestones.
Quick Reference Guide (QRG) – delivered in 3 weeks*
QRG’s typically accompany a standard or complex IFU for an at-home diagnostic, drug delivery, pharmaceutical, or combination device, and can be communicated in 5-10 steps.
What’s included
check_circleSingle page (double sided)
check_circleApplied Customer Branding
check_circle5-10 illustrations
check_circle1 iteration per Usability Evaluation
check_circleCopy (300 words)
check_circleFDA : 21 CFR 801.5 – Medical Devices; Adequate Directions for Use
check_circleFDA: ‘Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers’,
check_circleIEC/IEEE: 82079-1:2019 for Information for Use
check_circleIEC: 60601-1 requirements for the labeling and the accompanying documents (IFU) of Medical Electrical Equipment
check_circleANSI/AAMI/IEC: 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
check_circleANSI: Z535.6 for Safety Messages
check_circleISO: 3864 international standards for safety symbols
PDF and source files included
$18K
*key assumptions:
- The QRG is being developed in parallel to a full manual
- A uFMEA / critical task analysis / TUEA of the device exists
- CAD or a prototype of the device exists.
- Prompt, collated feedback will be returned at iteration milestones.
Surgical Training Guide (STG) – delivered in 8 weeks*
A Surgical Training Guide (STG) accompanies surgical instruments or devices and shows how they are appropriately used throughout a clinical procedure for training purposes.
What’s included
check_circle80 pages
check_circleApplied Customer Branding
check_circle60 illustrations (anatomical)
check_circle1 iteration per Usability Evaluation
check_circleCopy (30,000 words)
check_circleFDA : 21 CFR 801.5 – Medical Devices; Adequate Directions for Use
check_circleFDA: ‘Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers’,
check_circleIEC/IEEE: 82079-1:2019 for Information for Use
check_circleIEC: 60601-1 requirements for the labeling and the accompanying documents (IFU) of Medical Electrical Equipment
check_circleANSI/AAMI/IEC: 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
check_circleANSI: Z535.6 for Safety Messages
check_circleISO: 3864 international standards for safety symbols
PDF and source files included
$124K
*key assumptions:
- A uFMEA / critical task analysis / TUEA of the device exists
- CAD or a prototype of the device exists.
- Prompt, collated feedback will be returned at iteration milestones.
HCP Training Guide – delivered in 6 weeks*
A Health Care Professional Training Guide accompanies surgical or diagnostic instrument or devices and shows how they are appropriately used throughout a clinical or diagnostic procedure for training purposes.
What’s included
check_circle80 pages
check_circleApplied Customer Branding
check_circle60 illustrations
check_circle1 iteration per Usability Evaluation
check_circleCopy (30,000 words)
check_circleFDA : 21 CFR 801.5 – Medical Devices; Adequate Directions for Use
check_circleFDA: ‘Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers’,
check_circleIEC/IEEE: 82079-1:2019 for Information for Use
check_circleIEC: 60601-1 requirements for the labeling and the accompanying documents (IFU) of Medical Electrical Equipment
check_circleANSI/AAMI/IEC: 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
check_circleANSI: Z535.6 for Safety Messages
check_circleISO: 3864 international standards for safety symbols
PDF and source files included
$84K
*key assumptions:
- A uFMEA / critical task analysis / TUEA of the device exists
- CAD or a prototype of the device exists.
- Prompt, collated feedback will be returned at iteration milestones.