Classification of the Reseller of Stand Alone Medical Device Software

K

Kuhalit

#1
Hello, does your notified body also classify the reseller (with distributing / electronic installatio (actually only installer) as a supplier... with all the actions, which are required for supplier

Please tell me your experience.

Best regards
Andreas
 
Elsmar Forum Sponsor

c.mitch

Quite Involved in Discussions
#2
Hi Andreas
I don't know your context but probabilities are high that this reseller is considered as a supplier of a critical service. Critical because a failure of this supplier (eg defect in sw configuration management) may lead to non-conformity of your product (wrong version delivered).
 
K

Kuhalit

#3
Hello, but the supply is only starting with an installer, like MS Office. Is this still critical for you? Of course, if he does customizing... and he mess up something, it might be critical, right?
 

c.mitch

Quite Involved in Discussions
#4
If the supplier is just delivering your installer "as is" and the job is done by the end-user, then this (the delivery) doesn't sound critical. He's just a distributor. If he does customization, then yes this sounds critical hence his errors might have severe consequences.
 
Thread starter Similar threads Forum Replies Date
T Classification Accessory Software medical device EU Medical Device Regulations 4
W AR and Device Classification EU Medical Device Regulations 2
C Classification - "Metabolic Means" EU Medical Device Regulations 5
G Software Medical Device Classification EU Medical Device Regulations 7
D MDR classification and DoC requirements Medical Device and FDA Regulations and Standards News 1
R Reusable Needle Guide Classification EU Medical Device Regulations 0
P Identifying GAMP Classification: GAMP 4 or GAMP 5 ISO 13485:2016 - Medical Device Quality Management Systems 1
S Classification of product (measuring or not?) CE Marking (Conformité Européene) / CB Scheme 5
F Product classification according to the 60601-2-57: Particular requirements [...] of non-laser light sources [...] IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
C Question on KAFO (Knee Ankle Foot Orthosis device) classification CE Marking (Conformité Européene) / CB Scheme 0
SANTHSH Consumables, Paints, End-covers, NDE Chemicals & Tools suppliers classification and evaluation Oil and Gas Industry Standards and Regulations 6
G Classification of a container containing a liquified gas EU Medical Device Regulations 0
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
B Nasal Saline Solution for Irrigation purpose classification EU Medical Device Regulations 0
S Classification of a Sterile Procedure Pack EU Medical Device Regulations 0
P Device Classification CE Marking (Conformité Européene) / CB Scheme 0
B IVDR Classification and accreditation CE Marking (Conformité Européene) / CB Scheme 0
R IEC 60601-2-57 light source classification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
N Cleanroom Classification Change Other Medical Device Related Standards 7
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
P Blood establishment computer software EU classification EU Medical Device Regulations 0
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
C MDR Classification Rule 10 EU Medical Device Regulations 16
C MDR software classification EU Medical Device Regulations 12
K Classification Rationale for class 1 EU Medical Device Regulations 3
K Question on MDR classification EU Medical Device Regulations 5
L Programmer accessories classification EU Medical Device Regulations 0
R ELISA reader - IVDR classification EU Medical Device Regulations 9
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 3
D Classification of product for clinical trials EU Medical Device Regulations 14
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Surgical Instrument Tray Classification EU Medical Device Regulations 7
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
K Biological indicator system classification under MDR EU Medical Device Regulations 2
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
nadhar2 Classification of Action Items Misc. Quality Assurance and Business Systems Related Topics 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
M Classification of Clean Rooms Other Medical Device Related Standards 9
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 8
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
M Barrier cream classification EU Medical Device Regulations 2
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 12
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
D Classification of Syringe (nozzle) of needle free injection system. EU Medical Device Regulations 8

Similar threads

Top Bottom