Any experience with cCSAus Mark for US and Canadian markets?

B

bjarket

#1
Dear friends,
I've been suggested that we obtain a cCSAus mark for the American and Canadian markets instead of the ETL mark we have had on our older products. This mark will in our case be cheaper and faster to get than the ETL listing.

As this may very well be accepted regulatory by the US and Canada, I would very much like to know of any practical experience with the cCSAus mark: Is it practically accepted by the health care providers and insurance companies? Will I find that our product can't be sold because of local/in-house policies?

Thanks for your help!

Maybe I should add that our product is a hand-held medical device for in-vitro diagnostics.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: Any experience with cCSAus Mark?

ETL or CSA or UL are all widely accepted marks. In any case you are to face the quarterly unannounced safety audit and maintain the product in line with the reports which lists the safety critical components to use and safety tests and other construction details and proper use of the mark to be followed. Follow-up services cost may differ from one another. However the best agency to decide about your case for the mark can be the insurance company and / or customer. c and us along with ETL or CSA or UL mark are generally well accepted across USA and Canada.
 
S

somerqc

#3
Re: Any experience with cCSAus Mark?

I don't know the medical device industry; however, I have been dealing with the cCSAus and cULus for 10 years now.

In the last couple of years, it has been MUCH easier for manufacturers and customers to have either the CSA or UL logo on the equipment/components that they make or use.

There has been a crackdown recently by CSA (more experience with them) to ensure all components are verified by either themselves or UL right down to the transformer due to "fraudulent" use of their logo and other ways people have used loopholes that previously existed.

I am sure this issue isn't any different in the medical device industry.

Anyone else out there that may be more familiar with CSA and medical devices?
 
M

MIREGMGR

#4
As this may very well be accepted regulatory by the US and Canada, I would very much like to know of any practical experience with the cCSAus mark: Is it practically accepted by the health care providers and insurance companies?
My experience has been that all of the customer regulatory-input-providers with whom we've had occasion to interact, have been aware that such marks come from NRTLs (Nationally Recognized Test Laboratories).

In the US, the NRTL recognition program is managed by OSHA. Their website is at http://www.osha.gov/dts/otpca/nrtl/index.html#nrtls, where you can see a list of all currently recognized participants, along with details on their individual scopes and other particulars.

Other than verification that the particular issue that is of approval-concern to you is within CSA's scope, I wouldn't expect any difference in customer reactions between an ETL mark and a CSA mark.
 
Thread starter Similar threads Forum Replies Date
M Experience and advice with certifications categories Training - Internal, External, Online and Distance Learning 3
O ASQ CQE Exam Experience, Home versus Exam Center ASQ - American Society for Quality 0
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
E Consultant with Office 365 experience Consultants and Consulting 2
N Any experience with Registrars that deny Certification to a Registrant? Registrars and Notified Bodies 4
BeaBea Registrars with VAR (Value Added Reseller) experience Registrars and Notified Bodies 8
Q Experience with Adobe Sign Document Control Systems, Procedures, Forms and Templates 3
S Experience working with TUV SUD or Rheinland, and/or BSI Registrars and Notified Bodies 5
C Experience with Agile PLM (Product Lifecycle Management Software) software from Oracle? Document Control Systems, Procedures, Forms and Templates 3
Gamula Product-Lifecycle-Management Experience Medical Information Technology, Medical Software and Health Informatics 9
D Experience with De Novo applications Other US Medical Device Regulations 8
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 3
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
T Training and experience - How do I document my experience and training Career and Occupation Discussions 5
D AEA (Aerospace Experience Auditor) Challenges - Finding availability of AEA for witness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
QIE Anyone have experience with BPA Quality (QMS system based on Office365/Sharepoint) Quality Assurance and Compliance Software Tools and Solutions 1
Rameshwar25 Min working experience for IATF 16949 third party auditor IATF 16949 - Automotive Quality Systems Standard 5
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
1 ISO Registrar with waste water treatment experience Registrars and Notified Bodies 1
A Anyone have experience with Transmille calibrators General Measurement Device and Calibration Topics 1
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
C IATF 16949:2016 New CSR (CQI´s) - Share your experience IATF 16949 - Automotive Quality Systems Standard 1
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
W Problems with our new Auditor (a Ph.D. with four months experience) ISO 13485:2016 - Medical Device Quality Management Systems 25
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Moncia Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L How to get more Auditing Experience Career and Occupation Discussions 11
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Does anyone have experience with how MDD unanounced audits of suppliers are going? EU Medical Device Regulations 21
D What is your experience with FDA using "mixed load" i EO sterilization Other Medical Device Related Standards 1
P CQE Work Experience - New to Industry Professional Certifications and Degrees 1
S Any experience on filling form, FDA 3654 for the DICOM standard? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
K SSBB Qualifications and Experience Requirements Professional Certifications and Degrees 2
S IRCA Lead Auditor Certificate based upon Work Experience ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
A MDS software - Does anyone have experience with iPoint? RoHS, REACH, ELV, IMDS and Restricted Substances 8
P Experience / advice for integrating API Q1 9th with a WCM program Oil and Gas Industry Standards and Regulations 5
D Experience with Notified Body - ITC from Czech Republic for Medical Devices Registrars and Notified Bodies 15
J Experience with Licensale Submission Portal for Medical Devices Other Medical Device Regulations World-Wide 1
D Any experience with the SME/AME/Shingo/ASQ Lean BOK/Certifications? Lean in Manufacturing and Service Industries 2
N Willing to share my experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
M Offered Management Position - Limited Experience - Any Concerns? Quality Manager and Management Related Issues 13
GStough Rx-360 - Has Anyone Used This and What Was Your Experience? Supplier Quality Assurance and other Supplier Issues 3
B Japan PAL QMS Audit Experience Other Medical Device and Orthopedic Related Topics 5
D Minimum requirements/experience/qualifications to be head of quality Career and Occupation Discussions 6
J Does anyone have experience in submitting TSE Dossiers to EDQM? EU Medical Device Regulations 1
I Validation Software Experience? (Valgenesis, etc.) Quality Assurance and Compliance Software Tools and Solutions 1
Colin Anyone with Experience of BS EN 1090? CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom