CMDCAS and dba's (Doing Business As)

R

RHein

#1
Ok, some quick background info. We were previously owned by a company, who sold us to a bigger company. We were placed under the umbrella of a division of the company and were "Company 2 dba US". Now our assets have been transferred to a different division and are once again a "Company3 dba US".

Here's my question, what needs to be listed on the license "US" or "Company 3 dba US"?
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#3
Ok, some quick background info. We were previously owned by a company, who sold us to a bigger company. We were placed under the umbrella of a division of the company and were "Company 2 dba US". Now our assets have been transferred to a different division and are once again a "Company3 dba US".

Here's my question, what needs to be listed on the license "US" or "Company 3 dba US"?
The name on your license has to correspond exactly with the name on your ISO 13485:2003 CMDCAS certificate.

You could have both "US" and"Company3 dbaUS" as long as they are both on your ISO 13485 certificate.
 
Thread starter Similar threads Forum Replies Date
L Need to register Medical Devices in Canada (FDA, HC, CMDCAS...) Canada Medical Device Regulations 3
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
M Changes in MDSAP regarding to CMDCAS - Are there any new additional requirements? Canada Medical Device Regulations 1
S Certification services for ISO 13485, CMDCAS 13485, and CE Markings Canada Medical Device Regulations 18
DEVigil Scope statement for CMDCAS Canada Medical Device Regulations 10
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
M The difference between PN-EN ISO 13485 and EN ISO 13485 CMDCAS ISO 13485:2016 - Medical Device Quality Management Systems 7
B Is the ISO 13485 auditor being too picky concerning CMDCAS? ISO 13485:2016 - Medical Device Quality Management Systems 5
E Anyone have experience with UL as ISO 13485/CMDCAS and MDD registrar Registrars and Notified Bodies 17
N New Certificate for ISO 13485 & CMDCAS has no product listed nor explicit CMDCAS refs ISO 13485:2016 - Medical Device Quality Management Systems 5
A Expired CMDCAS Certificate - Registrar has yet to send the new CMDCAS certificate Canada Medical Device Regulations 4
somashekar CMDCAS ISO 13485 for Contract Manufacturers Canada Medical Device Regulations 7
P New ISO 13485:2003 CMDCAS question - Company Restructured ISO 13485:2016 - Medical Device Quality Management Systems 5
B CMDCAS versus ISO 13485 - What are the additional requirements Canada Medical Device Regulations 21
T Distributor Agreement Required for CMDCAS? ISO 13485:2016 - Medical Device Quality Management Systems 7
P CMDCAS Checklist with the additional requirements for Health Canada Canada Medical Device Regulations 4
T Is CMDCAS and CE marking auditor training manditory for compliance to the standard? Other ISO and International Standards and European Regulations 2
C CMDCAS (Canadian Medical Devices Conformity Assessment System) for drugs ISO 13485:2016 - Medical Device Quality Management Systems 3
M Keep current ISO 13485 registrar AND add new for CMDCAS ISO 13485:2016 - Medical Device Quality Management Systems 13
S CSA Requirements - CMDCAS - ISO 13485 - Medical Xray camera for Canada ISO 13485:2016 - Medical Device Quality Management Systems 7
A CMDCAS Certification Requirements and Audit Preparation ISO 13485:2016 - Medical Device Quality Management Systems 2
GStough Looking for someone with experience in MDD, PPE, CMDR/CMDCAS regs General Auditing Discussions 1
H CMDCAS Certification and Canadian Medical Device Regulations Various Other Specifications, Standards, and related Requirements 4
Q ISO 13485 CMDCAS Registrar Recommendations Registrars and Notified Bodies 23
L Subcontractor in terms of CAN/CAS 13485:2003 CMDCAS vs. DIN EN ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 5
P Qualified Registration Bodies (CMDCAS) one has been suspended ISO 13485:2016 - Medical Device Quality Management Systems 4
P ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit ISO 13485:2016 - Medical Device Quality Management Systems 1
G The most effective way to integrate CMDCAS requirements into Quality Manual ISO 13485:2016 - Medical Device Quality Management Systems 4
H CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audits? Canada Medical Device Regulations 22
R Is Cpk calculation of dBA (noise level) valid? Capability, Accuracy and Stability - Processes, Machines, etc. 9
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
K The correct way of doing a 2 Sample T test Reliability Analysis - Predictions, Testing and Standards 7
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
Sidney Vianna Are the Accreditation Bodies doing their job? Keeping CB's accountable Registrars and Notified Bodies 0
GreatNate QMS in SharePoint - Is anyone doing this? Manufacturing and Related Processes 10
D Doing both a top-down and a bottom-up risk assessment - How to combine ISO 14971 - Medical Device Risk Management 13
D Do I need part variation while doing Destructive Variable Gage R&R MSA study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
A True purpose of doing EST (Electrical Safety Test) on medical device Other Medical Device Related Standards 3
supadrai d/b/a doing business as and the FDA US Food and Drug Administration (FDA) 1
Raffy What is the first step in doing PIA (Privacy Impact Assessment)? IEC 27001 - Information Security Management Systems (ISMS) 3
I AS9100D - Interview Request - I'm doing research Misc. Quality Assurance and Business Systems Related Topics 1
Q Doing an MSA on a Climatic Chamber Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
N Explanation - Quality means doing it right when no one is looking ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Sidney Vianna As a profession we, auditors, are not doing enough - Simon Feary speech Registrars and Notified Bodies 36
B Doing MSA Variables Data Study on Threads Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
D Are we doing enough to meet Identification and Traceability 7.5.3 Requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Who is doing BGA cross sectional analysis in assembled PCBA in INDIA? Reliability Analysis - Predictions, Testing and Standards 1
G Thoughts on Audit Finding for not doing Gage R and R for Visual Inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
AnaMariaVR2 What the Internet is Doing to Our Brains Coffee Break and Water Cooler Discussions 5

Similar threads

Top Bottom