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Is virtual manufacturing still possible under the IVDR?

Virtual manufacturing (Company A selling as its own an IVD made company B) has been and still is a very common practice in the IVD world. This was facilitated by the self-certification of most IVDs under the EU-IVD Directive. This presentation will explore whether this practice will still be possible under the IVDR and how to best manage the relationship between the legal manufacturer and the contract manufacturer.

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

IEC62304 and IEC 82304 detail the different aspects related to product realization as per ISO 13485, especially for the verification and validation activities. But what to do with Medical Devices when it comes to Artificial Intelligence or Machine Learning? How does this impact the verification and validation approach and what is a pragmatic way forward for static Artificial Intelligence, Dynamic Artificial Intelligence or Static Black Box Artificial Intelligence? Eager to know more, join us for this session!

Medical Devices Risk Management according to ISO 14971:2019

During this webinar, the process of risk management according to ISO 14971:2019 is explained, highlighting the changes compared to the old version of the standard.

Building Safe and Effective Medical Devices: A Deep Dive into the Design and Development Process

During this webinar, the process of Design and Development of Medical Devices according to ISO 13485 and applicable regulations will be explained, with practical yet simplified examples to illustrate the main concepts of the process. How to handle changes to Medical Devices will also be explained.

Clinical Evaluations and Clinical Investigations for Medical Devices under MDR

Are you involved in the development or evaluation of medical devices? Do you want to enhance your understanding of the Clinical Evaluation and Clinical Investigation processes?

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Are you submitting a Medical Device under MDR? In this webinar, you will learn more about the main points to consider.

Post-Market Surveillance requirements for Medical Devices and IVDs

Learn about the regulatory requirements for post-market surveillance (PMS) under the European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic medical device Regulations 2017/746 (IVDR).

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

Learn more about the second edition of GAMP 5 and find out what the new, updated and removed chapters to the guidance are.

Computer System Validation Courses

Stay on top of new trends and refresh your knowledge with the help of our CSV experts. Follow our FREE online CSV program.

Medical devices: urgent needs vs regulation

Learn about early verification in a stringent design control process to decrease Time to Market and master the full product lifecycle of medical devices, not the least in pandemics like COVID-19.​​​​​​​ ​​​​​​​

The basic concepts of the QbD methodology

Learn about the basic concepts of the QbD methodology and the main struggles of process optimization. Get an exclusive demonstration of the Scilife Quality by Design solution.

Intro to Cell and Gene therapy

In this webinar, you will learn more about the typical cell and gene therapy workflow process with a focus on manufacturing.

3D Printing in the Healthcare world

Learn about Medical Equipment manufacturing while meeting regulations, discover tips and tricks to efficiently 3D print and find out about the most common pitfalls you need to avoid when designing and producing Medical Equipment.

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Upcoming events

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Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.