SBS - The best value in QMS software

MDIC (Medical Device Innovation Consortium) and the "Case for Quality"?

J

Julie O

#1
#1
Anyone here know anything about the Medical Device Innovation Consortium (MDIC)?

Anyone here know anything about their "Case for Quality" project?

Anyone here listen in on their recent webex?
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
J

Julie O

#5
#5
Re: MDIC and the "Case for Quality"?

Yes, I have been to their website. I was hoping someone else here might have additional information/experience/history.
 
L

Lerotronic

#6
#6
Re: MDIC and the "Case for Quality"?

I have been following MDIC in the last year with regards to patient preference in benefit-risk assessment. Also virtual patients for clinical trials. Liked the webexs and it seemed the consortium is well recognised by the FDA. Need to check out Case for Quality to tell more.


Sent from my iPhone using Tapatalk
 
J

Julie O

#7
#7
Thanks for the response. I can't find many people in the medical device industry who have heard of them. I will follow up in a private message, since you seem to be the only one here who is familiar with them.

For others here who might like to know more, their webexs are available at no charge:

http://mdic.org/mdicx/

Their most recent webex was on the Case for Quality, May 10.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 0
N Medical device name in different countries EU Medical Device Regulations 4
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3

Similar threads

Top Bottom