Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Ever wondered what it really takes for manufacturers to break into the Medical Devices market?

On demand

1h

Medical Devices

English

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This webinar will provide you the major challenges in software qualification and classification for different functionalities. We explore MDR for software-hardware combinations and how AI is handled under the AI Act.

In addition, we will share essential resources, key standards, and guidance documents crucial for getting your product to market, from design and development to clinical evidence and technical documentation.

Speakers

Caroline Aernouts

Caroline Aernouts

Senior Consultant RA MD

With 3 years at the QbD Group as consultant in Regulatory Affairs for medical devices, Caroline’s main expertise lies in Medical Devise Software (MDSW). Before this, she spent 5 years at Materialise, focusing on MDSW and CM implants.

Pieter Smits

Pieter Smits

SaMD expert & Project manager

Pieter is a seasoned SaMD/MDSW expert with extensive experience in EU and US regulations and standards, especially in AI and cybersecurity regulatory requirements. His expertise covers compliance with regulations like MDR/IVDR and FDA legislation, alongside standards such as ISO 13485, IEC 62304, IEC 82304, ISO 62366, ISO 81001, and ISO 14971.

In addition to his technical expertise, Pieter brings valuable project management experience in the pharmaceutical and medical device industries, helping organizations solve complex problems and implement effective solutions to achieve their goals.

Pieter’s Mission: To prove that compliance and innovation can go hand in hand while staying at the forefront of the evolving landscape of SaMD/MDSW legislation and standards.