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.
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.
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.