Cost of CE Marking

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I3CGLOBAL

CE Mark certificate

Health & Medicine

Europe and U.S.A
Medical Device
Regulatory & Q A Consultancy

Making the way of documents accepted by all regulators
Making the path clears for early certification / approvals
Making more savings to clients by providing very economic service from INDIA
Making us to grow along with you
Making excellence a habit

Class of Medical Device
# Activity
1 1s/m 11a 11b 111
01 Guidance on MDD Requirements related to your Device Free Free Free 200 200
02 Identification of Class and Harmonized Standards 100 200 200 300 400
03 Preparation of Technical file / Design Dossier 600 800 1000 1200 1400
04 Support in closing NB reviewer comments 400 500 600 700 800
05 Label Review 100 200 200 300 300
06 European Union Representative Agreement Free Free Free Free Free

07 Additional Fee for Animal Origin Medical Devices 400
08 Additional Fee for Radiation Emitting Medical devices 600
09 OBL / PLM CE Certification Discount 10 % 20 % 20 % 20 % 20 %
Fee mentioned above is in USD
Payment Terms 50 % advance, Balance after completing the work
Minimum Timeline 30 Days
Agreement / MOU Will send from office after project confirmation
Method of communication Telephone / Skype / G talk
Document Storage Cloud Drop Box / Sugar Sync
*Rate applicable for Europe and USA only

More information Click here

Interested? Download application form

www.i3cglobal.com

E Mail to – enquiry@i3cglobal.com

India - + 91 80 5064 8432

USA - + 1 6030 270 2921

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The FDA 510(k) Pre-submission, categorized under the Quality Submission (Q-sub) program, plays a pivotal role in medical device development. Manufacturers can proactively seek guidance from the FDA before submitting their premarket applications, such as IDEs, PMAs, HDEs, de novo requests, or 510(k)s. This voluntary interaction fosters a collaborative environment where sponsors can clarify doubts, address regulatory concerns, and align their submissions with FDA expectations. Ultimately, this proactive engagement enhances the efficiency and success of the regulatory process, ensuring safer and more innovative medical devices reach the market. Engaging in the FDA 510(k) Pre-submission process offers several distinct advantages for medical device manufacturers. Firstly, it allows sponsors to tap into the expertise of FDA reviewers early in the development cycle. This means that potential issues or concerns can be identified and addressed proactively, reducing the likelihood of costly delays during the formal submission process. Moreover, the Pre-submission process fosters transparency and open communication between manufacturers and the FDA. This collaborative approach helps build mutual trust and ensures that regulatory requirements are well-understood, ultimately streamlining the path to market approval. Furthermore, by seeking feedback through the Pre-submission program, manufacturers can enhance the quality of their submissions, increasing the chances of successful clearance or approval. This, in turn, benefits patients by ensuring that medical devices on the market meet the highest standards of safety and efficacy. In summary, the FDA 510(k) Pre-submission program is a valuable tool that empowers manufacturers to navigate the complex regulatory landscape with confidence, leading to better outcomes for both industry stakeholders and the patients who rely on these innovative medical devices.

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