Welcome to the IVD Manufacturing Channel!
I am an IVD Manufacturing Professional with 13+ years of experience in the Medical Device and In Vitro Diagnostics (IVD) industry. As a Gold Medalist, ISO 13485:2016 Certified Lead Auditor (TÜV), IVD Consultant, and YouTube Educator, I am passionate about sharing practical knowledge and industry expertise.
This channel provides valuable insights into IVD manufacturing, medical device plant setup, quality assurance, regulatory affairs, CDSCO MDR 2017, ISO 13485, MDSAP, WHO-PQ, lean manufacturing, production, operations, and quality management systems (MD-QMS).
Having worked with international manufacturers and suppliers across Germany, China, South Korea, the UAE, and other global markets, I bring real-world experience in manufacturing, compliance, audits, technology transfer, and operational excellence.
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IVD MANUFACTURING
🎥 Upcoming YouTube Video Announcement
📘 Plant Master File (PMF) Explained | CDSCO MDR 2017
I’m excited to announce my upcoming YouTube video where I’ll be breaking down Plant Master File (PMF) requirements as per CDSCO Medical Device Rules, 2017.
This video is designed for:
✔️ Medical Device & IVD Manufacturers
✔️ Regulatory Affairs & QA Professionals
✔️ Consultants & Compliance Teams
✔️ Anyone involved in CDSCO approvals
🔍 What you’ll learn:
What is a Plant Master File (PMF)?
Why PMF is critical for CDSCO compliance
Key sections & documentation requirements
Practical tips to avoid common regulatory gaps
📅 Video releasing soon on YouTube
👉 Stay tuned and subscribe to my channel for structured guidance on CDSCO MDR 2017, PMF, DMF, and regulatory approvals.
Your support, shares, and feedback mean a lot 🙌
#PlantMasterFile
#PMF
#CDSCO
#CDSCOMDR2017
#MedicalDeviceRegulations
#RegulatoryAffairs
#IVDManufacturing
#QualityCompliance
5 months ago | [YT] | 0
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IVD MANUFACTURING
1 year ago | [YT] | 2
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IVD MANUFACTURING
Hello Connections ....
Are you really interested in knowing about US FDA 510(k) Clearance Process then wait is over....
Upcoming Video on 510(k) Clearances-FDA|Premarket Notifications 510(k)|510(k) Submission Process|Medical Device Entry| stay tuned on my channel to be published on 25/08/2024 @ 12:00 IST... 💉
1 year ago | [YT] | 3
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IVD MANUFACTURING
For my lovely subscribers ....
2 years ago | [YT] | 3
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IVD MANUFACTURING
True but more often ...
2 years ago | [YT] | 1
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IVD MANUFACTURING
Launch of National Single Window System (NSWS) Portal by CDSCO.
Existing Portal to get disabled with immediate effect from 15/01/2024 for MD-01,MD-12 & MD-16.
#cdsco
#medicaldevices
#ivd
2 years ago | [YT] | 2
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IVD MANUFACTURING
Happy Diwali to all my lovely subscribers.....
2 years ago | [YT] | 3
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IVD MANUFACTURING
Follow the I.V.D Manufacturing channel on
WhatsApp: whatsapp.com/channel/0029Va95z5MEgGfUUXGlTB3Y
2 years ago | [YT] | 2
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IVD MANUFACTURING
Top 10 Q.A which can bring manufacturers very close to Customers.Which means delivering Product or Services following the SQDC Principle.
#Safety
#Quality
#Delivery
#Cost
2 years ago | [YT] | 3
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IVD MANUFACTURING
Good Morning Connection ,
As per new CDSCO Notification/ circular relaxation have been provided for
additional 6 months to import/ manufacture Class C&D MD by those manufacturers who have applied either the import or manufacturing license application.
Let's gear up Manufacturers .
#CDSCO
#IVD
#MEDICAL DEVICE
@ivdmanufacturing7208
2 years ago | [YT] | 1
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