With the FDA setting the Quality Management System Regulation (QMSR) implementation deadline for February 2, 2026, medical device manufacturers need to prioritize compliance to avoid receiving noncompliance during FDA audits. This deadline marks a critical shift towards aligning with ISO 13485. I3CGLOBAL offers a team of regulatory experts, highly experienced in FDA QSR and ISO 13485 standards now equipped with large resources for QMSR globally. Partnering with I3CGLOBAL ensures tailored support in QMSR implementation, ensuring compliance with ISO 13485 and QMSR requirements efficiently. Read more:https://lnkd.in/giGhz34z #fdaqmsr #qmsr #qualitymanagementsystemregulation
I3CGLOBAL
Business Consulting and Services
Bangalore, Karnataka 2,632 followers
A Trustworthy company. Sustainable partner for CE, UKCA & USFDA. One-Stop solution for your Regulatory needs
About us
I3CGLOBAL is a vibrant and customer-focused company that provides healthcare product manufacturers across the globe with US, EU & India medical device regulatory consultation services. We Have More Than 20+ Years Practical Experience. and we care deeply about what we do and the impact we have with our clients and with the communities in which we work and live. It is personal to all of us. Our Core values shape the culture of our organization and define the character of our company I3CGLOBAL insists on honesty, integrity, and fairness in all aspects of our business and expects the same in its relationships with domestic and international customers. This has earned the trust and respect from our existing customers and is acknowledged as the best! Our strong technical team spread in three continents along with their commitments to core values has helped I3CGLOBAL build long-term, value-centric relationships with customers and become one of the best and dependable global US FDA Agent & EU Medical Device Regulatory Consulting Company.
- Website
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https://www.i3cglobal.com/contact-us/#contactusform
External link for I3CGLOBAL
- Industry
- Business Consulting and Services
- Company size
- 51-200 employees
- Headquarters
- Bangalore, Karnataka
- Type
- Partnership
- Founded
- 1999
- Specialties
- CE Marking, US FDA Registration & Listing, EN ISO 13485:2012, and US DMF Preparation & Submission
Locations
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Primary
Get directions
S8, J J Park 02
DRC Post
Bangalore, Karnataka 560029, IN
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Get directions
75 Executive Drive, Suite 303
Aurora
Chicago, ILLINOIS 60504, US
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Get directions
Neidenburger Straße 20
Bremen, 2228207 28207, DE
Employees at I3CGLOBAL
Updates
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Outsourcing your 510(k) preparation and submission to I3CGLOBAL can significantly simplify the process and assure your chances of a 510k clearance. The 510(k) process can be complex, requiring in-depth knowledge of FDA guidelines, substantial documentation, and adherence to strict timelines. When you outsource to I3CGLOBAL, you tap into a team of regulatory experts specializing in 510(k) submissions, with over 280 successful 510(k) clearances worldwide We guide you through every step of the process and ensure that your submission is complete, well-organized, and aligned with FDA requirements, thus reducing the chances of requests for additional information (AI letters) that could delay market approval. We handle the preparation of critical documents, including the 510(k) Summary, device descriptions, substantial equivalence claims, and detailed testing reports (bench, biocompatibility, electrical safety, etc.). Our familiarity with predicate devices helps us navigate the substantial equivalence argument, ensuring your device is compared effectively to an already-cleared device, which is a key aspect of a successful submission. By outsourcing, you not only save time and resources but also reduce the risk of errors that could lead to submission rejections or delays. Our understanding of FDA expectations streamlines communication and makes the entire process more predictable. Ultimately, outsourcing your 510(k) preparation and submission to I3CGLOBAL allows your team to focus on day-to-day activities while we take care of submission and FDA communications. Request Quote: https://lnkd.in/gR-7hshd #fda510k #510kconsultants #510kclearance
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Quality Assurance and Regulatory Affairs Expert for Medical Devices EU CE marking, US FDA, Indian CDSCO
I’m happy to share that I’ve started my Master of Technology - MTech at Birla Institute of Technology and Science, Pilani!
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