Operon Strategist
Operon Strategist
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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/new-guid...
operonstrategist.com/eu-mdr-i...
operonstrategist.com/medical-...
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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?
Переглядів: 91

Відео

CE or US FDA 510(k): What Should You Choose for Your Medical Device?
Переглядів 876Рік тому
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
Переглядів 964Рік тому
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
Переглядів 755Рік тому
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.🩺
Переглядів 1,8 тис.Рік тому
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
Переглядів 375Рік тому
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
Переглядів 258Рік тому
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 ?
Переглядів 3,4 тис.Рік тому
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/?U...
Drug Device Combination products certificate for medical devices
Переглядів 260Рік тому
Drug Device Combination products certificate for medical devices
Best Turnkey Project Consultant For Medical Devices
Переглядів 1,4 тис.Рік тому
Best Turnkey Project Consultant For Medical Devices
UKCA Marking for medical Devices
Переглядів 384Рік тому
UKCA Marking for medical Devices
Registration Certificate for the Sale or Distribution of Medical Devices
Переглядів 8 тис.Рік тому
Registration Certificate for the Sale or Distribution of Medical Devices
CDSCO Notification for Class A Non-sterile and Non measuring Medical Device
Переглядів 5412 роки тому
CDSCO Notification for Class A Non-sterile and Non measuring Medical Device
CDSCO Notification for Class A Non-sterile and Non measuring medical devices
Переглядів 2 тис.2 роки тому
CDSCO Notification for Class A Non-sterile and Non measuring medical devices
( SFDA) Saudi Arabia FDA Medical Device Registration Process.
Переглядів 1,7 тис.2 роки тому
( SFDA) Saudi Arabia FDA Medical Device Registration Process.
Challenges to import medical devices in India
Переглядів 3352 роки тому
Challenges to import medical devices in India
Challenges for importing Medical Device in India
Переглядів 4332 роки тому
Challenges for importing Medical Device in India
How to start manufacturing medical devices
Переглядів 6262 роки тому
How to start manufacturing medical devices
Newsletter for Medical Device Regulatory updates - "Reguveda"
Переглядів 1532 роки тому
Newsletter for Medical Device Regulatory updates - "Reguveda"
Operon Strategist | Medical Device Regulatory Consultant
Переглядів 5672 роки тому
Operon Strategist | Medical Device Regulatory Consultant
Turnkey Project Consultant For Medical Devices
Переглядів 1542 роки тому
Turnkey Project Consultant For Medical Devices
US FDA 510(k) Clearance & Premarket approval-Operon Strategist
Переглядів 4722 роки тому
US FDA 510(k) Clearance & Premarket approval-Operon Strategist
CDSCO Import License consultant for medical device
Переглядів 7722 роки тому
CDSCO Import License consultant for medical device
CDSCO Import License for Medical Devices-Operon Strategist
Переглядів 8702 роки тому
CDSCO Import License for Medical Devices-Operon Strategist
Turnkey Project Consultant For Medical Devices
Переглядів 2482 роки тому
Turnkey Project Consultant For Medical Devices
How to start Medical Device Manufacturing | Operon Strategist
Переглядів 7202 роки тому
How to start Medical Device Manufacturing | Operon Strategist
What is MDSAP And Why is it required?
Переглядів 7572 роки тому
What is MDSAP And Why is it required?
FDA 510 k Clearance & Premarket Approval
Переглядів 1902 роки тому
FDA 510 k Clearance & Premarket Approval
Best Turnkey Project Consultant For Medical Devices
Переглядів 4962 роки тому
Best Turnkey Project Consultant For Medical Devices
Medical Device Manufacturing Consultants | Operon Strategist
Переглядів 1,1 тис.2 роки тому
Medical Device Manufacturing Consultants | Operon Strategist

КОМЕНТАРІ

  • @joyceeseconors5436
    @joyceeseconors5436 26 днів тому

    Taylor David Martinez Gary Walker Jose

  • @AbhishekrajKS
    @AbhishekrajKS 3 місяці тому

    What is the procedure for Requesting Corrections in the Registered certificate

  • @PoonamKumari-ep6ol
    @PoonamKumari-ep6ol 4 місяці тому

    link or header to pay MD 41 fees in Chandigarh

  • @lifewithabus
    @lifewithabus 4 місяці тому

    How can i update my warehouse location in SFDA

  • @ektasingh8945
    @ektasingh8945 4 місяці тому

    Very informative and to the point

  • @CAYASHVARSHNEY
    @CAYASHVARSHNEY 7 місяців тому

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

  • @maverick_mando
    @maverick_mando 7 місяців тому

    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 10 місяців тому

    "promosm"

  • @latikapatil706
    @latikapatil706 11 місяців тому

    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 Рік тому

    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

  • @pravinsirvi2689
    @pravinsirvi2689 Рік тому

    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 Рік тому

    Sir, competent person can be Bcom Graduate?

  • @dipakkumar-cp9cl
    @dipakkumar-cp9cl Рік тому

    Where can I register sir

  • @creativitymusic
    @creativitymusic Рік тому

    Nice video

  • @aryangaming165
    @aryangaming165 Рік тому

    sir how to fill that form

    • @OperonStrategist
      @OperonStrategist Рік тому

      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 Рік тому

    New initiative and good for the manufacturers

  • @bunnybun047
    @bunnybun047 Рік тому

    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 Рік тому

      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 Рік тому

    Does a digital thermometer come under class A

    • @OperonStrategist
      @OperonStrategist Рік тому

      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 Рік тому

    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 Рік тому

      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 Рік тому

    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 Рік тому

      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 Рік тому

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

    • @OperonStrategist
      @OperonStrategist Рік тому

      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 Рік тому

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

    • @OperonStrategist
      @OperonStrategist Рік тому

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

  • @pradeepadsule4353
    @pradeepadsule4353 Рік тому

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

    • @OperonStrategist
      @OperonStrategist Рік тому

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

  • @Santosh_361
    @Santosh_361 Рік тому

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

    • @OperonStrategist
      @OperonStrategist Рік тому

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

  • @preritsharma9272
    @preritsharma9272 2 роки тому

    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 роки тому

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

  • @gautamchoudhary1392
    @gautamchoudhary1392 2 роки тому

    Sir how to apply for MD 42 licence?

    • @OperonStrategist
      @OperonStrategist 2 роки тому

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

  • @mukeshp1427
    @mukeshp1427 2 роки тому

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

  • @mukeshp1427
    @mukeshp1427 2 роки тому

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

  • @Jain.harsh96
    @Jain.harsh96 2 роки тому

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

    • @OperonStrategist
      @OperonStrategist 2 роки тому

      Please mail your product list to enquiry@operonstrategist.com

  • @mukeshp1427
    @mukeshp1427 2 роки тому

    New Portal when will establish or already established?

  • @mukeshp1427
    @mukeshp1427 2 роки тому

    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 роки тому

    ρɾσɱσʂɱ

  • @sunilsunnyvlog5122
    @sunilsunnyvlog5122 2 роки тому

    Nice

  • @chetan8177
    @chetan8177 2 роки тому

    What about export license.?

    • @OperonStrategist
      @OperonStrategist 2 роки тому

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

  • @ketanparmar8688
    @ketanparmar8688 3 роки тому

    Your contact Number plz

  • @grungemax
    @grungemax 3 роки тому

    Some useful tips in the slides.

  • @poojasadgir7659
    @poojasadgir7659 4 роки тому

    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 роки тому

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