Conference Day Two

10:00 am - 12:00 pm Exemplary quality assurance according to a regulatory directive (MDR)

Gregor Reischle - Head of Additive Manufacturing, TÜV SÜD

In this exclusive workshop, we present the state-of-the-art methodology on how we, as TÜV SÜD, tackle the different challenges of complying to the regulatory framework, by presenting four different examples of necessary quality assurance (QA) procedures. These examples answer questions on how to build up your production site on an industrial level, how the necessary documents for QA can look like and what to consider for them, and how an AM compliant risk management and validation looks like and what pit falls need to be taken care of.

img

Gregor Reischle

Head of Additive Manufacturing
TÜV SÜD

1:00 pm - 1:00 pm Start of conference day two

1:00 pm - 1:30 pm Topic to be announced shortly

1:30 pm - 1:45 pm Q&A reserved


2:00 pm - 2:30 pm How can we establish a more effective mobilisation medtech network?

Dr Paul Unwin - Chairman, Additive Manufacturing UK Strategy Steering Group
  • Discover how the National Strategy (published in September 2017) provides recommendations to enable the UK industry to unlock the full commercial potential of additive manufacturing 
  • Understand how to overcome these challenges to unlock the significant potential benefits to the health sector
  • Discuss why AM is a ‘must have’ for the UK’s high value manufacturing sector to remain competitive globally
img

Dr Paul Unwin

Chairman
Additive Manufacturing UK Strategy Steering Group

2:30 pm - 2:45 pm Q&A with Dr Paul Unwin, Chairman, Additive Manufacturing UK Strategy Steering Group

Dr Paul Unwin - Chairman, Additive Manufacturing UK Strategy Steering Group


img

Dr Paul Unwin

Chairman
Additive Manufacturing UK Strategy Steering Group

3:00 pm - 3:30 pm From cyborgs and viruses: 3D printing fights Corona

Are all people with artificial or mechanical prostheses cyborgs? This controversial question may be answered with several examples of medical applications where additive manufacturing is applied. Additive manufacturing, or 3D printing, has become a major contributor when creating medical devices: Prostheses, implants, anatomical models, medical devices and pharmaceuticals - the list is long. Personal protective equipment is another area where manufacturing and supply chains have largely come to a standstill during the Corona pandemic - another area where additive manufacturing has stepped in. Our MGA network with its divisions Mobility and Medical is the leading international network for industrial additive manufacturing. With our initiative 3D Printing fights Corona, MGA has played a leading role by providing targeted information, organising calls-for-help / donations and establishing contacts during the Corona lockdown.

3:30 pm - 3:45 pm Q&A with Dr. Cora Lüders-Theuerkauf, Network Manager, Medical goes Additive


4:00 pm - 4:30 pm Must-haves for medical additive manufacturing based on regulatory directives and guidelines (MDR, FDA, IMDRF)

Gregor Reischle - Head of Additive Manufacturing, TÜV SÜD

All industries, especially medical, want to use the potential of AM for series production and mass-customisation. However, to do this, a wide variety of regulations, standards, guidelines and laws must be followed, which rarely take AM into account. So what are the “Must-haves” to ensure that all these requirements are met and the final product is conform to the different regulations and directives.

img

Gregor Reischle

Head of Additive Manufacturing
TÜV SÜD

4:30 pm - 4:45 pm Q&A with Gregor Reischle, Head of Additive Manufacturing, TÜV SÜD

Gregor Reischle - Head of Additive Manufacturing, TÜV SÜD
img

Gregor Reischle

Head of Additive Manufacturing
TÜV SÜD

4:45 pm - 4:45 pm End of conference day two