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Is ISO 13485 mandatory for medical devices

Is ISO 13485 Certification mandatory for medical devices ?

Post author:Gqsindia
Post published:November 17, 2022
Post category:ISO 13485 Certification ISO 13485 Certification in Bangalore ISO 13485 Consultancy Bangalore ISO 13485 Consultant ISO 13485 Consultant bangalore ISO 13485 Consultants Bangalore
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Is ISO 13485 mandatory for medical devices ? Just listen up!! There won’t be any excuse if the medical device companies are not complying with the medical device quality system…

What are Class 1, 2, 3 Medical Devices ?

Post author:Gqsindia
Post published:January 19, 2022
Post category:ISO 13485 ISO 13485 Certification ISO 13485 Consultant ISO 13485 medical device documentation ISO 13485-2016

It is highly important that the medical devices must be tested properly and proved safe! The European Union (EU MDR) classification will bring you all about the classification of medical…

Ganesh Chandrasekhar

4 months ago

“Global Quality Services consistently demonstrates exceptional professionalism, reliability, and commitment to excellence. Their team possesses deep industry knowledge and delivers high-quality results with remarkable precision and efficiency. The level of customer support, responsiveness, and attention to detail truly sets them apart from others in the industry. Every interaction reflects integrity, transparency, and a genuine dedication to client satisfaction. I am thoroughly impressed with their standards of service and would highly recommend Global Quality Services to anyone seeking dependable and world-class professional solutions.”

Gowtham Rao Salunke

3 years ago

Best of Best

Sameer Attari

4 years ago

Easy way to get certified

Mahesh Vijay

Vijaya Kumara v

Nagaraj MP

7 years ago

i sharing mine real experience... our company started ISO certification go through GQS Banglore Office.

> Here office environment very nice from Office Recp to HOD
> Mr.Sunil Shenoy sir ( Excellent in Tech knowledge ) & Mr.Rajendra sir
(Excellent in client coordination ).they are interact each and every
process crystal clear and friendly
> over all mine experiences good on the certification process and i hope
the same will be continue the up to certification validation .

Jeejo Mohan

8 years ago

Thanks to the instructor and team for making my training very pleasant and informative . I have acquired a good knowledge on the auditing process and i am sure this will add value to any employer I work for in future . I will be happy to recommend any one for the course . J Mohan

MANJUNATH G

We would like to express to you our sincere thanks and appreciation for your input and training procedures, and for working closely with our appointed team and our quality assigned team to assist us in this venture. We are confident in moving forward that our targets for improvement and the development of meaningful process performance measurements can only be enhanced, and we can attribute those results to your diligence and expertise in setting up our program and working closely with our appointed team.

We look forward to a continued relationship with you in assisting us with our internal audits as required, and to providing us with your input and assistance in maintaining our IS09001:2015 Quality Management System.

Once again, we would like to say very thankful to you for sharing your knowledge and wisdom with us

GS ENTERPRISES

Training on ISO 9001:2015 awareness and Internal Quality Auditor training was very useful, well presented.

Is ISO 13485 Certification mandatory for medical devices ?

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