Meeting the In Vitro Medical Devices Regulation In-House Training

Name: Meeting the In Vitro Medical Devices Regulation In-House Training
Brand: GLC Europe
SKU: event
Rating: 4.5 (10 reviews)

The aim of this In-house training is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance.

The aim of this In-house training event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.

Key learnings

Understand

Understand the intentions of the law

Requirements

Requirements of manufacturers, importers & distributors

Meeting

Meeting the Safety and Performance Requirements

Reporting

Post-market reporting requirements

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Masterclass Overview Img

Overview

The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. The aim of this In-house training event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.

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Trainer

Richard Tully

Director
Compliant Medical devices Ltd

My name is Richard Tully, currently the Director at Compliant Medical Devices Ltd. We are a medical device consultancy company who specialise in the European and Saudi Regulations. I started my professional life as an electrical engineer and had a lot of fun working off-shore and in dozens of different factories as part of a specialist electrical company. I went back to school at Brunel University to play with much lower voltages and completed my Masters in silicon design. I remained in engineering and expanded into mechanical, pneumatic and software design.

Who should attend img RECOMMENDATION

Who should attend?

• IVD Regulatory Affairs managers

• IVD Quality Managers

• IVD Quality Engineers

• Manufacturers of IVDs for the EU

• Designers of IVDs for the EU

• Anyone tasked with IVDR implementation

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

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"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

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"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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