Get FREE 12-month access to the AI-Powered Knowledge Base worth $450
with your ISO 9001 toolkit purchase
Limited-time offer – ends June 27, 2024

Free webinar – What Has Changed in the IVD Industry After EU IVDR – Challenges and Implementation

Presenter (in English): Sundeep Agarwal

Sundeep Agarwal
Webinar designed for all stakeholders involved in the process of adherence to the European Commission’s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017/746) requirements. That includes manufacturers, suppliers, notified bodies, competent authorities, authorised representatives, importers, etc. Globally, from 26th May 2022 IVD, manufacturers will have to comply with the EU IVDR. Gear up for the next level and execute accordingly.

Language: English

Format: Recorded webinar

Duration: 67m 30s (1h 7m 30s)


You may unsubscribe at any time.

For more information on what personal data we collect, why we need it, what we do with it, how long we keep it, and what are your rights, see this Privacy Notice.

Register for this webinar to learn:

  • Key changes due to IVDR
  • Need for a QMS
  • New product classification
  • Essential role of notified bodies
  • CE certification process
  • Supplier & sub-contractors management
  • Unannounced audits
  • Performance evaluation plan & report

Target audience:

This training is designed for technical employees related to quality, regulatory, supply chain, and clinical, including:

  • Director/VP – Quality/QMS/ Regulatory Affairs
  • COO – Strategic Planning
  • Regulatory/Quality Affairs Head
  • Quality Assurance Manager
  • Manufacturing or Production Head
  • Quality Assurance Engineers
  • Quality Control Officers
  • Quality & Regulatory Affairs Specialists
  • Regulatory/Quality Associates
  • Regulatory Consultants
  • Clinical or Medical Writers

Presented by: Sundeep Agarwal

Sundeep AgarwalWith a Master of Technology in Quality Management and a decade of experience in medical and IVD devices & life sciences, Mr. Sundeep Agarwal is a leader, speaker, trainer, and consultant in the fields of Quality Assurance, Regulatory Affairs, QMS, Software Validation, Artificial Intelligence, Combination Devices, GCP, Design & Development, Risk Management, and Industrial Manufacturing. He is a lead auditor for medical devices and has expertise in ISO 13485, EU MDR, IVDR, CE Certification, CER, PMS, USFDA, 510(K), ISO 14971, and MDSAP.

Mr. Agarwal has delivered multiple global webinars on medical/IVD devices and life sciences topics. He is also a prominent guest lecturer at various MBA and pharmacy educational institutions in India and an active member in a Technical Group in the Asian Harmonization Working Party.

Related Frequently Asked Questions

In which language are the webinars delivered?

Live online trainings via webinars are currently delivered in English only. However, we plan to deliver some of the trainings in other languages, too.

Are these trainings held in person, at a specific venue?

No, all our live online trainings are delivered through Internet only, via webinars. Webinars enable you to experience both audio and video presentation from our presenter/trainer.

What do I need to watch the webinars on Demand (recording of live online streaming)?

You just need your computer with a browser - webinar recordings can be watched as any other video on the internet, e.g. on YouTube.

How many times can I watch the webinar recordings?

The number of views is not limited - you can watch the recordings as many times you wish.

About 13485Academy


13485Academy is one of the Academies of Advisera specializes in helping organizations implement top international standards and frameworks such as EU GDPR, ISO 27001, ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, ISO/IEC 17025, AS9100 and ISO 20000. Over the years, Advisera has become a global leader in the provision of web-based training and documentation developed by the leading experts.

Our products are of best-in-class quality. With a proven performance record of successful implementations in more than 100 countries, our world-class customer support ensures success. Read more about the 13485Academy here.

100% Secure Online Billing


We use Secure Socket Layer (SSL) technology, the industry standard and among the best available today for secure online commerce transactions. All of your personal information, including credit card number, name, and address is encrypted so it cannot be read during transmission. You are protected by your credit card company in the case of a fraudulent transaction with any purchase.


AES-256bit SSL safe Privacy Policy

Online payment services are provided by BlueSnap and 2Checkout.