Operon Strategist
Operon Strategist
  • 79
  • 81 739
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...
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

วีดีโอ

CE or US FDA 510(k): What Should You Choose for Your Medical Device?
มุมมอง 936ปีที่แล้ว
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
มุมมอง 1Kปีที่แล้ว
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
มุมมอง 817ปีที่แล้ว
If you're planning to import Class C&D medical devices into India, CDSCO registration and license is mandatory. Learn more about CDSCO Import: 🤔 operonstrategist.com/services/regulatory-approvals/cdsco-registration/cdsco-import-license/? . Find out how to get in touch with us here: operonstrategist.com/contact-us/? . Want to Visit our website? Click here: operonstrategist.com/? . Let’s Connect!...
Register your Medical Device in CDSCO India.🩺
มุมมอง 1.9Kปีที่แล้ว
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
มุมมอง 462ปีที่แล้ว
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
มุมมอง 272ปีที่แล้ว
Medical devices must comply with the ISO 13485 standard to ensure safe and effective use. This video explores the major benefits of ISO 13485 certification for medical devices. If you're planning to manufacture or sell medical devices, then it's important to know about the ISO 13485 certification process. This video will show you the major benefits of ISO 13485 certification and explain why it'...
How to get your CE Mark Certification for Medical Devices ?
มุมมอง 3.5K2 ปีที่แล้ว
This video will show you how to get your CE Mark Certification for Medical Devices. Understand the process of getting CE marking Certification. CE marking is a procedure that every medical device needs to go through in order to be marketed in the EU. . . . To know more about CE marking Certification for medical devices visit here: operonstrategist.com/services/regulatory-approvals/ce-marking/?T...
Drug Device Combination products certificate for medical devices
มุมมอง 2902 ปีที่แล้ว
Drug Device Combination products certificate for medical devices
Best Turnkey Project Consultant For Medical Devices
มุมมอง 1.5K2 ปีที่แล้ว
Best Turnkey Project Consultant For Medical Devices
UKCA Marking for medical Devices
มุมมอง 4792 ปีที่แล้ว
UKCA Marking for medical Devices
Registration Certificate for the Sale or Distribution of Medical Devices
มุมมอง 9K2 ปีที่แล้ว
Registration Certificate for the Sale or Distribution of Medical Devices
CDSCO Notification for Class A Non-sterile and Non measuring Medical Device
มุมมอง 5672 ปีที่แล้ว
CDSCO Notification for Class A Non-sterile and Non measuring Medical Device
CDSCO Notification for Class A Non-sterile and Non measuring medical devices
มุมมอง 2.1K2 ปีที่แล้ว
CDSCO Notification for Class A Non-sterile and Non measuring medical devices
( SFDA) Saudi Arabia FDA Medical Device Registration Process.
มุมมอง 1.9K2 ปีที่แล้ว
( SFDA) Saudi Arabia FDA Medical Device Registration Process.
Challenges to import medical devices in India
มุมมอง 3732 ปีที่แล้ว
Challenges to import medical devices in India
Challenges for importing Medical Device in India
มุมมอง 4492 ปีที่แล้ว
Challenges for importing Medical Device in India
How to start manufacturing medical devices
มุมมอง 6872 ปีที่แล้ว
How to start manufacturing medical devices
Newsletter for Medical Device Regulatory updates - "Reguveda"
มุมมอง 1572 ปีที่แล้ว
Newsletter for Medical Device Regulatory updates - "Reguveda"
Operon Strategist | Medical Device Regulatory Consultant
มุมมอง 6212 ปีที่แล้ว
Operon Strategist | Medical Device Regulatory Consultant
Turnkey Project Consultant For Medical Devices
มุมมอง 1572 ปีที่แล้ว
Turnkey Project Consultant For Medical Devices
US FDA 510(k) Clearance & Premarket approval-Operon Strategist
มุมมอง 4902 ปีที่แล้ว
US FDA 510(k) Clearance & Premarket approval-Operon Strategist
CDSCO Import License consultant for medical device
มุมมอง 7912 ปีที่แล้ว
CDSCO Import License consultant for medical device
CDSCO Import License for Medical Devices-Operon Strategist
มุมมอง 8992 ปีที่แล้ว
CDSCO Import License for Medical Devices-Operon Strategist
Turnkey Project Consultant For Medical Devices
มุมมอง 2532 ปีที่แล้ว
Turnkey Project Consultant For Medical Devices
How to start Medical Device Manufacturing | Operon Strategist
มุมมอง 8802 ปีที่แล้ว
How to start Medical Device Manufacturing | Operon Strategist
What is MDSAP And Why is it required?
มุมมอง 8092 ปีที่แล้ว
What is MDSAP And Why is it required?
FDA 510 k Clearance & Premarket Approval
มุมมอง 2002 ปีที่แล้ว
FDA 510 k Clearance & Premarket Approval
Best Turnkey Project Consultant For Medical Devices
มุมมอง 5032 ปีที่แล้ว
Best Turnkey Project Consultant For Medical Devices
Medical Device Manufacturing Consultants | Operon Strategist
มุมมอง 1.1K2 ปีที่แล้ว
Medical Device Manufacturing Consultants | Operon Strategist

ความคิดเห็น

  • @Zephy3
    @Zephy3 16 วันที่ผ่านมา

    I got here by smashing my keyboard

  • @AbhishekrajKS
    @AbhishekrajKS 6 หลายเดือนก่อน

    What is the procedure for Requesting Corrections in the Registered certificate

  • @PoonamKumari-ep6ol
    @PoonamKumari-ep6ol 7 หลายเดือนก่อน

    link or header to pay MD 41 fees in Chandigarh

  • @lifewithabus
    @lifewithabus 7 หลายเดือนก่อน

    How can i update my warehouse location in SFDA

  • @ektasingh8945
    @ektasingh8945 8 หลายเดือนก่อน

    Very informative and to the point

  • @CAYASHVARSHNEY
    @CAYASHVARSHNEY 10 หลายเดือนก่อน

    From where i can download format for Self-certificate of compliance with respect to Good Distribution Compliance

  • @maverick_mando
    @maverick_mando 10 หลายเดือนก่อน

    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 ?

  • @emmettunderwood6858
    @emmettunderwood6858 ปีที่แล้ว

    "promosm"

  • @latikapatil706
    @latikapatil706 ปีที่แล้ว

    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 ?

  • @anujbansal7381
    @anujbansal7381 ปีที่แล้ว

    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

    • @azsanwar5731
      @azsanwar5731 20 วันที่ผ่านมา

      brother apne md42 certificate kese liye bata sakte h

    • @anujbansal7381
      @anujbansal7381 20 วันที่ผ่านมา

      @ cdsco jana padta hai … waha woh log forms lete hai or certificate dete hai

  • @pravinsirvi2689
    @pravinsirvi2689 ปีที่แล้ว

    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

  • @vikrantshetty8257
    @vikrantshetty8257 ปีที่แล้ว

    Sir, competent person can be Bcom Graduate?

  • @dipakkumar-cp9cl
    @dipakkumar-cp9cl ปีที่แล้ว

    Where can I register sir

  • @creativitymusic
    @creativitymusic ปีที่แล้ว

    Nice video

  • @aryangaming165
    @aryangaming165 ปีที่แล้ว

    sir how to fill that form

    • @OperonStrategist
      @OperonStrategist ปีที่แล้ว

      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.

  • @kalidasdas2431
    @kalidasdas2431 ปีที่แล้ว

    New initiative and good for the manufacturers

  • @bunnybun047
    @bunnybun047 ปีที่แล้ว

    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.

    • @OperonStrategist
      @OperonStrategist ปีที่แล้ว

      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.

  • @devendragaur4659
    @devendragaur4659 ปีที่แล้ว

    Does a digital thermometer come under class A

    • @OperonStrategist
      @OperonStrategist ปีที่แล้ว

      No, Digital thermometer not come to the under class A. If You want more information you can call or whatsapp 9370283428 on this number.

  • @dr.virendhrrana741
    @dr.virendhrrana741 ปีที่แล้ว

    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.)

    • @OperonStrategist
      @OperonStrategist ปีที่แล้ว

      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.

  • @SarfarazAlam-gp5re
    @SarfarazAlam-gp5re 2 ปีที่แล้ว

    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

    • @OperonStrategist
      @OperonStrategist ปีที่แล้ว

      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

  • @ajkarlmax8700
    @ajkarlmax8700 2 ปีที่แล้ว

    Sir what the certificate required for domestic medical device manufacturers. Is the any specific certificate or approval required from ICMR?

    • @OperonStrategist
      @OperonStrategist 2 ปีที่แล้ว

      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.

  • @mukeshkumar-bq1nu
    @mukeshkumar-bq1nu 2 ปีที่แล้ว

    If anyone have wholesale licence do we need MD -41,42 licence?

    • @OperonStrategist
      @OperonStrategist 2 ปีที่แล้ว

      Not required for medical devices if already having Form 20/21B

  • @pradeepadsule4353
    @pradeepadsule4353 2 ปีที่แล้ว

    we located in Mumbai....since you are in pune

    • @OperonStrategist
      @OperonStrategist 2 ปีที่แล้ว

      Hello Pradeep Sir, Kindly reach out to us on +919370283428 and enquiry@operonstrategist.com

  • @Santosh_361
    @Santosh_361 2 ปีที่แล้ว

    Sir I have 20B & 21B LICENSE FOR SELL & distribut

    • @OperonStrategist
      @OperonStrategist 2 ปีที่แล้ว

      Hello Santosh, We can assist you with your requirement. Please reach out to 9370283428

  • @preritsharma9272
    @preritsharma9272 2 ปีที่แล้ว

    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

    • @OperonStrategist
      @OperonStrategist 2 ปีที่แล้ว

      Hello Prerit, We would be glad to assist you. Please get in touch with our team on 9370283428

  • @gautamchoudhary1392
    @gautamchoudhary1392 2 ปีที่แล้ว

    Sir how to apply for MD 42 licence?

    • @OperonStrategist
      @OperonStrategist 2 ปีที่แล้ว

      Hello Gautam, We would be glad to assist you. Please get in touch with our team on 9370283428

  • @mukeshp1427
    @mukeshp1427 2 ปีที่แล้ว

    A person who already having a wholesale license, it's mandatory to have registration certificate in Form MD-42.

  • @mukeshp1427
    @mukeshp1427 2 ปีที่แล้ว

    Now we can able to gohead to the SLA start apply for Registration certificate in MD-41.

  • @Jain.harsh96
    @Jain.harsh96 2 ปีที่แล้ว

    we are manufacturer for Freezers and refrigerators are we required any licence, we had a factory in AMTZ Vizac

    • @OperonStrategist
      @OperonStrategist 2 ปีที่แล้ว

      Please mail your product list to enquiry@operonstrategist.com

  • @mukeshp1427
    @mukeshp1427 2 ปีที่แล้ว

    New Portal when will establish or already established?

  • @mukeshp1427
    @mukeshp1427 2 ปีที่แล้ว

    This will be applicable for already CDSCO notified device which comes under non sterile, non measuring function of Class-A medical devices.

  • @raymondlee4569
    @raymondlee4569 2 ปีที่แล้ว

    ρɾσɱσʂɱ

  • @sunilsunnyvlog5122
    @sunilsunnyvlog5122 2 ปีที่แล้ว

    Nice

  • @chetan8177
    @chetan8177 3 ปีที่แล้ว

    What about export license.?

    • @OperonStrategist
      @OperonStrategist 3 ปีที่แล้ว

      Export Licenses are specific to the countries. Get in touch to know more on export for medical devices

  • @ketanparmar8688
    @ketanparmar8688 3 ปีที่แล้ว

    Your contact Number plz

    • @OperonStrategist
      @OperonStrategist 3 ปีที่แล้ว

      Hello Sir, Please contact us on 9370283428

  • @grungemax
    @grungemax 3 ปีที่แล้ว

    Some useful tips in the slides.

  • @poojasadgir7659
    @poojasadgir7659 4 ปีที่แล้ว

    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,

    • @OperonStrategist
      @OperonStrategist 3 ปีที่แล้ว

      We have come up with the Certification courses. Please find the details on this link : trainings.operonstrategist.com/certification-courses/