Healthcare Innovation Cycle for "MedTech" Solutions

MedTech is broad term for electro/mechanical medical devices. Tracking data has been added to show an example of an early stage team at risk due to a focus on technology. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description of what is involved in completing a requirement and curated resources.

MaturityDisplay

Back

Milestone

Requirement

Preliminary Risk and Hazard Analysis

An initial assessment of the potential risks and hazards associated with the results of using the solution
In addition to ultimately being required for regulatory approval, it is important to know the potential risks and hazards as soon as possible so mitigation plans can be made
Follow standard risk and hazard analysis procedures.

Asset Publisher

Talking to HCPs - Laura Johnson via LinkedIn.pdf

A guide to talking with healthcare providers

Related Assets

Rimsys-Ultimate-Guide-to-EU-MDR-IVDR-GSPR-2ED.pdf

With the initial rollout of the European Medical Device Regulation (MDR) complete, medical device companies
are shifting focus to the sister In Vitro Diagnostic Regulation (IVDR) that became...

Related Assets

Clear Product Requirements Document (PRD) - Guide and Checklist

https://www.greenlight.guru/blog/product-requirements-medical-devices

Related Assets

Legacy Impact

Previous Impact data can be found here.

CRAASH Schedule - BCN 2021

BCN CRAASH 2021 Schedule Date & Page Link Topic Time (CET) 27 July Orientation and Kick-Off Assignments 14:00 to 15:30 6-7 September In Person...

Terms of Service

Terms of Service for all CIMIT sites

Security and Privacy Policy

GAITS and CoLab Security and Privacy Policy

GAITS Terms of Service.pdf

GAITS Terms of Service.docx

GAITS Security and Privacy Policy.pdf

GAITS Security and Privacy Policy.docx

Agreements and Forms

how-hospital-administrators-make-purchase-decisions_research-studies.pdf

Google research on how hospital admins make purchasing decisions

Filing a US patent application on your own

Link

Related Assets

ISO-13485_Ultimate_Guide_Greenlight_Guru.pdf

THE ULTIMATE GUIDE TO ISO 13485:2016 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES - Greenlight Guru

Related Assets

Which Type of IP Protection Is Right for Your Medical Device?

Link

Related Assets

Clinical-Evidence-IVD-Framework-MDC.pdf

Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs)

Related Assets

IVD

IVD Specific Resources

HOW TO PLAN AND CONTROL THE DESIGN OF YOUR MEDICAL DEVICE WHILE MEETING REGULATORY EXPECTATIONS

Link

Related Assets

Ultimate Guide to Design Controls.pdf

Greenlight Guru guide to design controls for medical devices

Related Assets

CategoryFiltersPortlet