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A Day in the Life of a QbD MD Specialist

Medical devices are one of QbD's main areas of expertise. We support you from concept to launch in the full life cycle. Wondering what a day in the life of a QbD MD Specialist looks like? Let's take a look behind the scenes!
A Day in the Life of MD Specialist Steven

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A medical-device-packed day

Let’s follow Steven from 7:00 AM until 21.00 PM:

07:00 – SLEEP ANALYZER APP

My sleep app tells me it’s time to wake up. This app in itself is no medical device because it serves no medical purpose.

07:15 – TOOTHBRUSH

Brushing my teeth with an electrical toothbrush (class I). 
 
Toothbrush
Contact lenses

07:20 – CONTACT LENSES

Inserting my corrective contact lenses (Class IIa). The cleanser and disinfectant are considered a Class IIb devices. 
 

07:45 – FACE MASK

Off to work! I take the local bus to the office and put on my face mask (Class I) as required. 
 
Face mask
Alcohol gel

08:25 – ALCOHOL GEL

Before entering the office, applicable measures require me to disinfect my hands with alcohol gel (not a medical device, but a biocide).
 

08:30 – MRI SCANNER

Online meeting with a potential customer who is ambitious in bringing his state-of-the-art MRI scanner (class IIb) to market. It looks like we are on the right track!
 
MRI
Vascular Stent

10:30 – VASCULAR STENT

Coffee break with my colleague who recently got a vascular stent (Class III). I wonder if the biocompatibility safety standards (ISO 10993) were followed and what reusable surgical instruments (Class Is) were used.
 

11:00 – PMS APP

Got a customer question about patient management system software. Since this app connects to a patient’s real-time cardiac and oxygen parameters, it has to be validated as Software as a Medical device class IIa (ISO82304). 
 
PMS app
Health app

12:30 – HEALTH APP

Time for lunch. I go for my daily walk and check if I have met my daily steps with my health app, just for my information, so no medical device. 
 

13:30 – ISO13485

One of our clients needs to be ISO13485 certified by the end of the year, so I’m making sure – among other things – that all the critical service providers are checked. 
 
ISO
Knee bandage

16:30 – KNEE BANDAGE

Picked up my daughter from school. She fell and her teacher bandaged her knee (class I). I wonder what she used to disinfect the wound? Would it qualify as a medical device or drug? 
 

16:45 – GLUCOSE METER

Since my daughter has diabetes, we check her blood glucose level together (IVD Class C).  
 
Glucose meter
COVID test

17:00 – COVID-19 TEST

Just dropped by the pharmacy for a Covid-19 self-test (IVDR class C) before visiting my grandmother. They advertise fat-binding diet pills (XLS medical). Strangely, these are marketed as an MD.  
 

17:10 – HIP IMPLANT

On my way to visit my grandmother. She just got a new hip implant (class III). Fortunately, she is doing well. I am taking her for a ride in her new wheelchair (Class I).  
 
Hip implant
Sanitizer

20:00 – ISO14155

Watching television ads about a new toothpaste that protects against bleeding gums for which they cite clinical evidence. I wonder what such a clinical study would look like according to the ISO 14155 standard.  
 

21:00 – SCALE

Checking myself on the scale. Although it gives me useful info about my lifestyle, it is not a medical device.
 
Scale

As you can see, medical devices are everywhere! 

Need MD help and advice?

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