Development of Medical devices Flashcards
What’s the process of developing medical devices?
Idea
Market
Requirements
Development and testing
Business plan
–> final product
What are the three keys to understanding the needs?
- Etiology – Anatomy, physiology, pathophysiology
- Epidemiology – Prevalence and Incidence
- Care pathway – Diagnostics, Treatment, Follow-up
What are the three keys to understanding the market?
- Who are my customers?
- What is the industry like?
- Who is my competition?
Who is responsible for a medical product during its life cycle?
The manufacturer
What is MDR
Medical Device Regulation - Every medical device must follow it (comes from MDD, Medical Device Directive)
What does the CE mark indicate? What role does the manufacturer have?
According to the manufacturer’s assessment, the product complies with the EU’s standards for safety, health, and environmental protection
By affixing the CE marking, the manufacturer takes on legal manufacturer responsibility.
What is a notified body?
Companies/organizations designated to conduct third-party assessments of medical devices before they are placed on the market.
Higher risk classes: Notified body issues the certificate
True or false?
Certificate = CE-marked
False
What determines if a device is a medical device?
Intended use, for humans, for one or more of the following:
* diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease/injury/disability.
* investigation, replacement or modification of the anatomy or a physiological or pathological process or state.
* Provide information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.
* Also products used to clean/sterilise of some medical products
What determines the classification of a medical device?
Duration of contact
Degree of invasiveness
Anatomy affected
Active/non-active
How long is transient/short/long term use in terms of medical device classification?
<60 min
6min to 30 days
>30 days
How is a combination of products classified?
Individually
How is driving or affecting software classified?
Same as product
What are the 6 steps of risk management
Analysis of risk
Evaluation of risk
Control of risk
Evaluation of residual risk
Report of risk management
Reports from production and post-production
What is EMC?
ElectroMagnetic compatibility, is the ability of devices and systems to operate in their electromagnetic environment without impairing their functions and without faults and vice versa
