£354

Understanding Medical Device Regulations for Software Products

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Thorpe Park Hotel & Spa

1150 Century Way

Leeds

LS15 8ZB

United Kingdom

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Refunds up to 30 days before event

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Are you developing medical devices with software components?

Attend our training course to ensure the health of your business and patient by learning how to navigate the regulatory pathway to market

This course will demonstrate how the medical device regulations apply to your software. You will learn

  • Does your software qualify as a medical device?

  • How your software is classified

  • How to identify relevant directives, standards and guidance documents you need to develop your device according to the state of the art

  • How to develop and maintain your device for the EU market (CE mark), including design & development, quality management, compilation of technical file, conformity assessment, vigilance and post market-surveillance

The course will be delivered by Koen Cobbaert, Chair of Software Focus Group at COCIR and Senior Manager for Quality, Standards and Regulations at Philips. Koen has over 15 years experience in medical software; including in establishing regulatory strategies and bringing products to market.

The workshop will be beneficial to industry representatives, clinicians and academics

Delegate fee £295 + VAT, includes course information pack, lunch and refreshments throughout the day

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Date and Time

Location

Thorpe Park Hotel & Spa

1150 Century Way

Leeds

LS15 8ZB

United Kingdom

View Map

Refund Policy

Refunds up to 30 days before event

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