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Operon Strategist
India
เข้าร่วมเมื่อ 23 ม.ค. 2014
Targeting 10K subscribers...... Operon Strategist is a Regulatory Consultant for Medical Devices. Operon Strategist has last 12 years providing Turnkey solutions, including facility designing as per regulatory compliance and providing consultancy for all regulatory certificates like CDSCO Registration approval, European CE marking, SFDA, USFDA 510(k), UKCA, and other countries' registration. Operon Strategist has a global presence in 32 countries.
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Phone no - +91 9370283428 / 9028043428 / 9325283428
Mail ID - enquiry@operonstrategist.com
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how to get in touch with us: operonstrategist.com/contact-us/?
Want to visit our website? Click here: operonstrategist.com/?
Contact Us On 📞
Phone no - +91 9370283428 / 9028043428 / 9325283428
Mail ID - enquiry@operonstrategist.com
VISIT - operonstrategist.com
Please subscribe to our channel for new updates and videos, and hit the bell icon for new notifications.🔔🔔🤩🤩
Operon Strategist's Silver Partnership: 7th Annual Medical Device Regulatory and Quality Summit 2023
Discover Operon Strategist's proud Silver Partnership with the 7th Annual Medical Device Regulatory and Quality Summit 2023 by Inventicon - Business Intelligence. As a leading consultancy specializing in medical device regulatory and quality solutions, Operon Strategist's sponsorship reflects its commitment to advancing the industry's understanding of compliance and quality assurance. Join industry experts and thought leaders to explore regulatory updates, quality systems, and global harmonization trends, showcasing Operon Strategist's dedication to supporting medical device stakeholders in navigating complex regulations with confidence.
Learn more : operonstrategist.com/services...
EU MDR Transition:operonstrategist.com/dont-pro...
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operonstrategist.com/eu-mdr-i...
operonstrategist.com/medical-...
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Let’s Connect! 🤩🤩
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0:00 Introduction
0:44 What is the MDR Transition Extension and why is it Important?
2:04 What is the Length of Extention for Each Device?
2:51 What Conditions are Applicable for MDR Transition Extention?
4:13 How Can Companies Prepare for the MDR Transition & What Resources are Available to Help Them?
4:50 How Will the MDR Impact Patient Safety and Regulatory Compliance?
5:34 What are Some of the Potential Benefits & Challenges of the MDR Transition for Medical Device Manufacturers?
Learn more : operonstrategist.com/services...
EU MDR Transition:operonstrategist.com/dont-pro...
operonstrategist.com/eu-propo...
operonstrategist.com/new-guid...
operonstrategist.com/eu-mdr-i...
operonstrategist.com/medical-...
.
Find out how to get in touch with us here:
operonstrategist.com/contact-...
.
Want to Visit our website? Click here:
operonstrategist.com/?...
.
Let’s Connect! 🤩🤩
🤝Linked In: in.linkedin.com/company/opero...
🤝Facebook: operonstrate...
🤝Instagram: operon_stra...
🤝Twitter: operonstrategis?l...
🤝Don’t Forget to Subscribe:
/ @operonstrategist
...
Have you had a great experience with Operon Strategist? Let us know is the comment is below!
0:00 Introduction
0:44 What is the MDR Transition Extension and why is it Important?
2:04 What is the Length of Extention for Each Device?
2:51 What Conditions are Applicable for MDR Transition Extention?
4:13 How Can Companies Prepare for the MDR Transition & What Resources are Available to Help Them?
4:50 How Will the MDR Impact Patient Safety and Regulatory Compliance?
5:34 What are Some of the Potential Benefits & Challenges of the MDR Transition for Medical Device Manufacturers?
มุมมอง: 106
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CE or US FDA 510(k): What Should You Choose for Your Medical Device?
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Find out what should you choose for your medical device CE marking or US FDA 510(k) for approval of your medical device internationally. In this video, I will provide a comprehensive guide to the differences between these two paths, along with the pros and cons of each option. . . Learn more about US FDA 510(k):operonstrategist.com/services/regulatory-approvals/fda-510k/? . . Learn more about C...
EU MDR Transition extension : A complete Guide for Medical Devices
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This video podcast aims to provide a detailed overview of the new requirements and changes introduced in the MDR regulations. The MDR (Medical Device Regulation) transition video podcast is a comprehensive guide designed to help medical device manufacturers to navigate the EU Transition and its extension. The MDR Transition Guide is hosted by experts in the medical device industry who will prov...
Class C&D Medical Devices registration in India: CDSCO Registration
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Register your Medical Device in CDSCO India.🩺
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To ensure the safety and efficacy of medical devices, CDSCO regulates all medical devices in, India. For the import of any medical device in India it is mandatory to have a CDSCO import license. Also to manufacture any medical device it's mandatory to have a CDSCO manufacturing license. . This brief but informative video will give you a quick overview of some successful CDSCO registration of me...
Design & Development Documentation for Medical Device
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In this video, you can see the steps of design and development. Get the ultimate guide to designing and developing your medical device. Understand the step of Design & Development Documentation. Device design and development need deep analysis to evaluate the position in the marketplace of the new product. Operon Strategist is a leading medical device consultant, who assists Design & Developmen...
Major Benefits of ISO 13485 QMS for Medical Devices | Operon Strategist
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How to get your CE Mark Certification for Medical Devices ?
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I got here by smashing my keyboard
What is the procedure for Requesting Corrections in the Registered certificate
link or header to pay MD 41 fees in Chandigarh
How can i update my warehouse location in SFDA
Very informative and to the point
From where i can download format for Self-certificate of compliance with respect to Good Distribution Compliance
sir is' nt it compulsory for Class A non sterile non measuring device manufacturers to register their product on online system of medical devices ? How will I as a buyer check the authenticity of a Class A non measuring non sterile device if it isn't registered ?
"promosm"
I want to sell on orthopaedic surgery screw and plates for that i have msme registration certificate. Still i need to require this MD 42 ?
I am from Maharashtra. Can you please guide me how can I make payment of challan for MD41 application. (Registration under md 42) sale of medical device
brother apne md42 certificate kese liye bata sakte h
@ cdsco jana padta hai … waha woh log forms lete hai or certificate dete hai
Sir how can i classified the device? if device not categories according to schedule-1? What is parameters to classified the device? device is non-invasice
Sir, competent person can be Bcom Graduate?
Where can I register sir
Nice video
sir how to fill that form
Thanks for your message. Kindly reach out to our sales team on +91 9370283428. We will be able to provide you all the details on this.
New initiative and good for the manufacturers
I am selling dental products like lecron carver, mouth mirror etc from my home on amazon and flipkart which license I have required for selling this products.
Thanks for your message. Kindly reach out to our sales team on +91 9370283428. We will be able to provide you all the details on this.
Does a digital thermometer come under class A
No, Digital thermometer not come to the under class A. If You want more information you can call or whatsapp 9370283428 on this number.
I'm going to sell examination gloves. Is it required to get cdsco licenses for that purpose? I own website and my business model is dropshipping (we are not physically storing anything. When order arrived, company (Vandor) will transfer the order directly to customers, and I will get small amount of comission on each successful order.)
Dear Virendhr Sir, Thanks for your message. Kindly reach out to our sales team on +91 9370283428. We will be able to provide you all the details on this.
Dear Sir Good Day to you, Sir i want to sell Glucometer in over all India , and the manufacturing product is from Saudi Arabia What certificate are required for me. Thank you
Hello Sarfaraz, you will need to apply for import license for Glucometer. We can completely assist you for the same. Kindly reach out to us on enquiry@operonstrategist.com or +919370283428
Sir what the certificate required for domestic medical device manufacturers. Is the any specific certificate or approval required from ICMR?
Hello AJ There is a requirement of CDSCO manufacturing license for Domestic Medical Devices manufacturers. And we can completely assist you for the same. Please reach out to us on bdm@operonstrategist.com or 9370283428. Requirement of ICMR depends on the product. We can discuss the same and clarify.
If anyone have wholesale licence do we need MD -41,42 licence?
Not required for medical devices if already having Form 20/21B
we located in Mumbai....since you are in pune
Hello Pradeep Sir, Kindly reach out to us on +919370283428 and enquiry@operonstrategist.com
Sir I have 20B & 21B LICENSE FOR SELL & distribut
Hello Santosh, We can assist you with your requirement. Please reach out to 9370283428
Sir... Can we apply MD 41, 42 at our GST registered Resi cum office address ? or we need commercial office space to apply MD 42 etc
Hello Prerit, We would be glad to assist you. Please get in touch with our team on 9370283428
Sir how to apply for MD 42 licence?
Hello Gautam, We would be glad to assist you. Please get in touch with our team on 9370283428
A person who already having a wholesale license, it's mandatory to have registration certificate in Form MD-42.
No. Not required
Now we can able to gohead to the SLA start apply for Registration certificate in MD-41.
Yes
only when the portal is open or given any clarity by SLA
we are manufacturer for Freezers and refrigerators are we required any licence, we had a factory in AMTZ Vizac
Please mail your product list to enquiry@operonstrategist.com
New Portal when will establish or already established?
This will be applicable for already CDSCO notified device which comes under non sterile, non measuring function of Class-A medical devices.
Yes
ρɾσɱσʂɱ
Nice
What about export license.?
Export Licenses are specific to the countries. Get in touch to know more on export for medical devices
Your contact Number plz
Hello Sir, Please contact us on 9370283428
Some useful tips in the slides.
Glad you like them!
Nice video ,I am interested for learning, all registration, sugam poetal,lis renewal, copp registration but how learn, how to practice it any idea about all this profile please tell me,
We have come up with the Certification courses. Please find the details on this link : trainings.operonstrategist.com/certification-courses/