Mass ProductionMedicalStandards

TÜV SÜD publishes checklists for 3D printed medical devices

Focus on supply bottlenecks during supply chain disruption

Additive manufacturing bolsters local industries that need high-precision parts. The early months of the current pandemic strained global supply chains when such parts were needed most, particularly in medical applications. TÜV SÜD, a company that facilitates technology-driven change, has responded to this challenge by creating checklists that assist companies with retooling to produce high-grade medical parts.

The company’s emphasis on access to quality procedural information is yet another boon for the AM industry. COVID-19 has shown AM’s worth as a local manufacturing solution when international options are restri

cted. Checklists promote quality products, worker safety, and rapid retooling during crises.

The company is a success story through every industrial revolution to date. Founded in Baden, Germany, in 1866, at the tail end of the steam revolution, the company conducted technical inspections into the electrical age, with a focus on automobiles and elevators. The company entered the atomic age with an inspection portfolio that grew into technical service segments. The present corporation formed out of mergers at the end of the twentieth century. One of its focuses is technical regulation and service in additive manufacturing. The company continues to provide technical standards certifications, audits, and training.

TÜV SÜD’s experience in the medical additive manufacturing sector allowed it to produce detailed checklists in keeping with its focus on standard operating procedures. TÜV SÜD’s focus on the medical AM market responded to the immediate need for more AM-produced medical supplies.

Its continued focus, however, responds to the need for precision instruments in a profitable entry point for AM companies.

Workers consulting a checklist
Workers consulting a checklist

Checklists help manufacturers implement regulatory requirements reliably and promptly. The company’s checklists detail the main requirements across key standards and regulations relating to medical products. These lists were distributed to manufacturers free of charge during the COVID-19 crisis. The free lists benefitted testing laboratories, healthcare specialists and the public by making AM easier to access.

TÜV SÜD’s checklists join with international organizations’ efforts. ASTM International and the International Organization for Standardization, for example, provide free access to applicable personal protective equipment and medical device manufacturing standards.

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Adam Strömbergsson

Adam is a legal researcher and writer with a background in law and literature. Born in Montreal, Canada, he has spent the last decade in Ottawa, Canada, where he has worked in legislative affairs, law, and academia. Adam specializes in his pursuits, most recently in additive manufacturing. He is particularly interested in the coming international and national regulation of additive manufacturing. His past projects include a history of his alma mater, the University of Ottawa. He has also specialized in equity law and its relationship to judicial review. Adam’s current interest in additive manufacturing pairs with his knowledge of historical developments in higher education, copyright and intellectual property protections.

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