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Additive Manufacturing Standards For Medical Production

Additive Manufacturing Standards For Medical Production

Dedicated standards for medical devices produced using Additive Manufacturing are already in preparation. Gregor Reischle, Head of Additive Manufacturing at TÜV SÜD highlights the importance of additive manufacturing standards for medical devices and what manufacturers need to consider before they start. 

Gregor Reischle

Dedicated standards for medical devices produced using Additive Manufacturing are already in preparation. In future, they will smooth the path for the implementation of new technologies as well as their assessment for approval. In this interview with Asia Pacific Metalworking Equipment News (APMEN), Gregor Reischle, Head of Additive Manufacturing at testing, inspection and certification services provider TÜV SÜD, shares what aspects need to be considered against this backdrop.

Why do we need standards to help us use AM technology for medical production?

Gregor Reischle (GR): Items that are already produced using Additive Manufacturing, such as protective face coverings, masks and visors or products for radiation treatment, are subject to particularly rigorous conformity and safety standards. However, assessment procedures for approval of these products take time – and time is of the essence in a pandemic. Standards help to ensure regulatory requirements are implemented reliably, promptly and cost-effectively, thus minimising risks. They also represent state-of-the-art solutions and serve to concentrate specific knowledge.

There are still no Additive Manufacturing standards designed specifically for medical devices. Where can manufacturers seek guidance in the meantime?

GR: We have drawn up checklists for all the most important requirements in the main standards and regulations relating to Additive Manufacturing, covering those that set out more general terms as well as the first more specific requirements. We are currently providing the checklists free of charge International standard organisations such as ASTM International and ISO are likewise providing access to relevant standards free of charge at the moment, for items such as personal protective equipment and medical devices. This benefits testing laboratories, healthcare specialists and the general public.

How widespread are 3D-printed medical devices?

GR: Conventionally manufactured products still make up the majority. Anyone using 3D printing today is pursuing strategic aims and is willing to invest a lot of time in such products. Additive manufacturing is only widespread in specific areas of medical engineering, like prosthetics and dental technology. In fact, probably all the major manufacturers in the dental industry now supply 3D printers, some of which can even be used in medical practices. 

What changes will the MDR introduce in this respect compared to its predecessor, the MDD?

GR: Under the Medical Device Directive (MDD), these “custom-made products” can be used without the need for CE marking. Although the same will apply under the Medical Device Regulation (MDR), manufacturers of class III implantable custom products will now need to call in a Notified Body to perform conformity assessment of their quality management system. Many products will fall into a higher class under the MDR, and this may require the involvement of a Notified Body in some cases. Custom-made products will be replaced by a common basic model which is customised for patient-specific use.

How will upcoming standards support the requirements to fulfil regulatory requirements such as MDR conformity? And which existing standards could already be useful?

GR: The requirements of the MDR state that a Notified Body must assess the manufacturer’s quality management system and verify compliance of its processes with the state of the art. DIN SPEC 17071—the specification for requirements concerning quality-assured processes at additive manufacturing centres—can usefully be applied here. The guideline is aimed at minimising risks stemming from parts and components produced using Additive Manufacturing, irrespective of the industry or sector. A project to transfer these findings to medical engineering is already under way, and a white paper on the subject will be published very soon. The DIN SPEC 17071 will also be advanced to reach the international ISO/ASTM level; the upcoming ISO 52920 and 52930 represent state-of-the-art quality assurance for AM production.

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Achieving Global Market Access For XEV Battery Systems

Achieving Global Market Access For xEV Battery Systems

The market for advanced electric vehicles (xEVs) is continuing to expand worldwide. Developers and original equipment manufacturers (OEMs) are facing growing numbers of regulations and standards addressing the safety and performance of the battery systems used to power these vehicles. Although many of these regulations touch on similar considerations, there are also important differences that must be taken into account during the various stages of battery design. Further, the regulatory approval process in key markets is often unique to a given country, and the successful navigation of this process requires a specific approach.

TÜV SÜD has published a new white paper to discuss the key safety and performance issues that must be addressed in all xEV battery designs as well as the special requirements applicable to xEV battery systems in the EU, the USA, China and other major markets worldwide.

“The continual innovation and high quality of batteries and battery systems will be a key factor in boosting consumers’ acceptance of xEVs. For the manufacturers of xEV batteries and battery systems, market access for their products depends on how successfully they can fulfil the requirements and standards of the regulatory authorities in the major automotive markets of the world,” said Johannes Roessner, Global Focus Segment Manager, New Energy Vehicles at TÜV SÜD and author of the white paper.

Evaluation of the safety and performance of chargeable batteries and battery systems is a critical element in the development of xEVs and xEV technologies. International standards play a major role in this process, and compliance with the requirements of the standard contributes to improving battery safety. Validation of safety, right from the design and development process, further paves the way for the products to pass the tests required by the regulatory authorities.

The OEMs of xEV batteries and battery systems must foresee the complexity and challenges involved in different homologation issues in key automotive markets and be prepared to tackle them. By working proactively with third-party expert organisations to address these issues in advance, OEMs can proceed more efficiently and effectively and achieve faster global access for their products.


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3D-Printed Medical Devices Can Remedy Supply Bottlenecks In Times Of Pandemic

3D-Printed Medical Devices Can Remedy Supply Bottlenecks In Times Of Pandemic

During the coronavirus pandemic, the 3D printing industry has successfully set up on-demand production facilities. Medical devices are subject to strict quality requirements and must conform to an array of legal regulations. In addition, there is a shortage of contract manufacturers able to fulfil these conditions. To mitigate the situation, TÜV SÜD has drawn up a range of checklists for production processes and is providing them to manufacturers. The company is also involved in numerous initiatives.

“When borders are closed to stop the spread of COVID-19, companies are forced to adjust their supply chains”, says Gregor Reischle, Head of Additive Manufacturing at TÜV SÜD. Additive manufacturing sites using 3D printers quickly reacted by concentrating resources and reducing the pressure on supply chains. 3D printing technology was one area of focus as an option for filling gaps in supply chains, most urgently concerning nasal swabs, ventilator components and personal protective equipment (PPE). At present, additive manufacturing is also boosting supplies of key products such as face visors, ventilator valves, filters, pressure sensors and X-ray tubes for applications ranging from general healthcare to high-precision personalised devices for even the most niche markets.

The benefits of additive manufacturing in a growing market

Even before the current pandemic, analysts had forecast that the market for additive manufacturing in the medical sector would grow to be worth at least US$ 20 billion. The market for AM in dentistry is set to reach US$ 9.7 billion by 2027 with impressive annual growth of 35 per cent.

Additive manufacturing offers the significant advantage of being able to close supply chain gaps by promptly ramping up capacities in series production when needed. The technology enables complex fully functional designs to be manufactured as a single piece, eliminating the need for subsequent assembly of individual parts. This can often result in higher-quality products. It also offers the capability of creating cost-effective prototypes while shortening development lead times. The pandemic has proved that both these methods can succeed – but also revealed the extensive array of device-specific provisions and regulatory requirements which apply to the products.

Medical devices must be high-quality, high-performance and safe. Proof of their compliance with numerous conformity and safety standards must be furnished before they can be placed on the market. The products may also be subject to further specific purpose-related requirements. Personal protective equipment must protect the wearer from particles, droplet aerosols and similar (Regulation (EU) No. 2016/425). Particularly rigorous conformity and safety standards apply to face masks and visors for use in hospitals and clinics. The necessary conformity assessment takes time, which is at a premium during a pandemic.

Checklists smooth the way for market access

Guidelines help manufacturers to implement regulatory requirements reliably and promptly. To assist them in this, TÜV SÜD has drawn up checklists for the main requirements addressing additive manufacturing, both general and specific, in key standards and regulations, and has been supplying these checklists free of charge to manufacturers in the coronavirus crisis. The lists are a boon for testing laboratories, healthcare specialists and the public. In addition, international standards organisations such as ASTM International and ISO provide free access to the relevant standards concerning the manufacture and testing of personal protective equipment and medical devices.

Additive manufacturing therefore is playing a useful role in battling the pandemic and is fostering willingness to innovate, which is impacting positively on the medical and healthcare sector in general. “There are many indications that fast, integrated supply chain networks with local production operations will become the new normal”, says Gregor Reischle. But the support provided by TÜV SÜD as an impartial third party is not confined to checklists. The technical service provider also develops specific tests for additive manufacturing operations which assure the quality and consistency of industrial additive series manufacturing. With the help of the tests, contract 3D printing companies can verify their conformity with the requirements set forth in the MDD and MDR.

Initiatives and projects for combating the pandemic

Governments and industry associations, multinational companies and start-ups are turning to platforms aimed at closing knowledge gaps in the industry. Siemens has provided its 3D printers to doctors, hospitals and manufacturers in need of development of medical devices or components. In addition, the company is networking its entire supply chain from the design and simulation phases through to production.

Singapore’s AM accelerator, National Additive Manufacturing Innovation Cluster (NAMIC), has set up a website containing a comprehensive list of COVID-19 resources for medical institutions, hospitals and medical device suppliers, which can then work with 3D printing hubs to design, optimise and print parts for vital healthcare equipment.

In Singapore, TÜV SÜD participated in an inter-agency collaboration between the Health Science Authority, Nanyang Technological University (NTU) and NAMIC, aimed at guiding manufacturers through testing requirements to fulfil them reliably and rapidly. Checklists for face visors and nasal swabs are available free of charge from NAMIC’s COVID-19 response platform.

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Siemens Launches Advance Manufacturing Competence Center In Singapore

Siemens Launches Advance Manufacturing Competence Center in Singapore

Siemens has officially launched its Advance Manufacturing Transformation Center (AMTC) to provide guidance, support and training to companies in Southeast Asia on their journey of adoption, transition and transformation towards advance manufacturing.

AMTC is the first-of-its-kind, three-in-one competence center that combines the Digital Enterprise Experience Center (DEX), the Additive Manufacturing Experience Center (AMEC) and Rental Labs – creating a one-stop advance manufacturing ecosystem that addresses operational transition.

The DEX showcases Digital Enterprise solutions that enable companies to create digital twins of their envisioned advance manufacturing plants, so that they can simulate, optimize and evaluate manufacturing operations before constructing the actual manufacturing environment. It also provides manufacturing design consulting.

The AMEC is where companies can experience hands-on exposure to an advance end-to-end additive manufacturing production line supported by AMTC’s ecosystem of technology partners. It fills the gap between additive manufacturing R&D and commercialization by letting companies carry out prototyping, supported by on-site additive manufacturing experts.

The Rental Labs (Additive Manufacturing) provide affordable access to the latest industrial design software and high-end additive manufacturing printers as well as post-processing equipment – allowing companies to do low-volume 3D printing for proof of concept, and testing of such production line before deciding if they want to invest in additive manufacturing infrastructure.

Minister Chan Chun Sing congratulated the launch of the Siemens AMTC with a video message.

Minister Chan Chun Sing congratulated the launch of the Siemens AMTC with a video message.

“Today, most companies understand the urgent need for digital transformation, and the disruption brought on by the COVID-19 pandemic has emphasized that. But many companies are deterred by factors such as complex and unintegrated technologies, high cost of transition, disruption to business continuity and lack of technical experts,” said Raimund Klein, Executive Vice President of Digital Industries, Siemens ASEAN. “Siemens is supporting companies in their transition into Industry 4.0 with the AMTC, a consulting, training, R&D and small-scale production facility, all rolled into one.”

As a testament of how the AMTC can help to accelerate production introduction cycle, the center and its partners developed and manufactured a medical grade face shield using additive manufacturing in June this year. The face shield was designed by Tan Tock Seng Hospital (TTSH) for its COVID-19 front-liners. The optimized face shield has enhanced durability and strength, provides comfort wear and allows ease of cleaning.

Siemens, through the AMTC, is partnering SkillsFuture Singapore to roll out a six-month additive manufacturing training under the SGUnited Mid-Career Pathways Programme. The programme equips mid-career jobseekers with skills in additive manufacturing and digitalization to move into roles such as Programmable Logic Controller engineers and automation engineers, so as to better support the current wave of industrial companies undergoing digital transformation. The AMTC will host projects for trainees to work on and organise Project Demonstration Days for trainees to pitch their projects to potential hiring employers.

“The launch of its Advance Manufacturing Transformation Center reflects Siemens’ continued confidence in Singapore as a leading location to spur regional development and adoption of Advanced Manufacturing. We believe it remains relevant and will catalyse the digital transformation of businesses in the new operating environment,” said Lim Kok Kiang, Executive Vice President, International Operations, EDB. “We are also heartened that Siemens is supporting our mid-career professionals with training opportunities during this challenging period, and equipping them with skills for the future.”

The AMTC ecosystem currently consists of technology providers, education and research institutes, as well as government agencies. They are:

Technology Providers

Education and research institutes

Government agencies


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TÜV SÜD And Thyssenkrupp Innovations Sign MoU To Develop Additive-Manufacturing-Enabled Eolutions In APAC

TÜV SÜD And thyssenkrupp Innovations Sign MoU To Develop Additive-Manufacturing-Enabled Eolutions In APAC

TÜV SÜD, has signed a Memorandum of Understanding (MoU) with thyssenkrupp Innovations to establish the principles governing their cooperation in jointly developing the market for additive-manufacturing-enabled solutions in the Asia Pacific region. The companies will work together over a period of three years, starting with setting up industrial grade manufacturing solutions as well as testing, inspection and certification services for land transportation and mobility, and industrial plant services. The companies may expand the scope of the MoU to cover other sectors as well.

The partnership will combine thyssenkrupp Innovations’ expertise in part selection and design advisory services with TÜV SÜD’s capabilities in regulatory and non-regulatory testing and certification, to offer predictable innovation management solutions for customers, which will result in mitigating risk, investment security, easier access to global markets, and faster time-to-market. The combined capabilities of the two companies will enable them to expand their respective market reach and offer expanded services to existing as well as new customers. The two companies are currently working on testing and commercialising a train part for a leading train operator in the region to reduce the overall weight and improve its functionality significantly.

Mr. Holger Lindner, CEO of TÜV SÜD Product Service Division said, “The field of additive manufacturing (AM) is an integral pillar of Industry 4.0. AM presents new opportunities for serial production and supply chains but early adopters will need to navigate through uncertainties in this fast evolving technology. Through this collaboration with thyssenkrupp, we aim to inspire trust among the frontrunners and demonstrate Singapore’s readiness for industrial grade additive manufacturing.”

Mr. Jan Lueder, CEO thyssenkrupp RHQ Asia Pacific said, “thyssenkrupp has always stood for engineering excellence and innovation for over 200 years with deep experience in automotive, mobility and industrial plant sectors. Additive manufacturing delivers enormous potential to transform the region and level up vital sectors of the economy, reducing import dependence and simplifying supply chains. Additive manufacturing will surely be an innovative solution to further drive growth, as long as stakeholders work together to continue building awareness as well as create a supportive ecosystem for additive manufacturing adoption and development. The collaboration is thus a step towards this direction, and we are sure we will be able to provide best services to our customers.”


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TÜV SÜD PSB Signs MoU With NUS For Medical Device Additive Manufacturing

TÜV SÜD PSB Signs MoU With NUS For Medical Device Additive Manufacturing

TÜV SÜD has signed a Memorandum of Understanding (MoU) with the NUS Centre for Additive Manufacturing (AM.NUS) at the National University of Singapore (NUS), to promote R&D activities in the area of 3D printed biomedical implants for clinical trials.

AM.NUS seeks to bring innovative products to the field of healthcare that will improve patient outcomes and change lives for the better. The centre strives to explore a whole new dimension in Medical Additive Manufacturing, applying innovative 3D printing technology for personalised patient treatments.

TÜV SÜD as a premier third-party quality assurance organisation, works closely with the industry in providing them with the right expertise in the areas of certification, inspection and auditing. With its suite of service offerings, the company has partnered AM.NUS to provide Medical AM Certification ISO 13485 and certification services and other quality assurance requirements. The centre will be the first in Singapore to attain both the AM Design and Development and ISO 13485 certification. These certifications apply to the centre’s facility located at the NUS Faculty of Engineering, which will fabricate 3D printed metal implants for clinical trials.

At the signing ceremony, Richard Hong, CEO, TÜV SÜD ASEAN, said, Additive Manufacturing is ushering in transformation in the production of medical devices as the technology is enabling businesses to push boundaries. We are excited to work with AM.NUS, as this collaboration makes us the first company to certify the first AM Design and Development that can print 3D printed metal implants for clinical trials.”

Additive Manufacturing technology can be considered as a great opportunity to provide easy access to healthcare in developing countries. It is a crucial step towards engineering patient-specific medical products. Thus, it is imperative to meet the global standards while developing these products. Partnership with TÜV SÜD is of strategic importance since it will help us achieve global standards while we build and strengthen our base in the region,” said Professor Jerry Fuh Ying-Hsi, Director of AM.NUS, who is also from the Department of Mechanical Engineering at the NUS Faculty of Engineering.

The MoU between AM.NUS and TÜV SÜD will bring together both companies in their concerted efforts to define new frontiers in R&D in the space of 3D printing of medical implants.


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TÜV SÜD Rallies For Smart Manufacturing In Singapore

TÜV SÜD Rallies For Smart Manufacturing In Singapore

MUNICH/SINGAPORE: Global figures show that Industry 4.0 has the potential to increase annual revenues by up to US$1.5 trillion in value to the global economy by 2022 and enable a seven fold increase in overall productivity. Meanwhile, in January 2018, the World Economic Forum identified Singapore as one of the countries best positioned to benefit from advancements in manufacturing and smart factories.

Speaking at the inaugural Industrial Transformation Asia-Pacific (ITAP) conference which is a Hannover Messe event taking place in Singapore this week, Dr. Andreas Hauser, Director, Digital Service Centre of Excellence, TÜV SÜD said: “With the right approach, the positive impact of Industry 4.0 could be tremendous, particularly in markets like Singapore, where manufacturing accounts for a fifth of GDP and 400,000 jobs. However, many companies we spoke to find it hard to formulate an Industry 4.0 roadmap which is customised according to their strengths and challenges. They are often overwhelmed by the multitude of technologies in the market and how they can be integrated seamlessly into their infrastructure.” In response to this need, the TÜV SÜD Digital Service Centre of Excellence in Singapore has launched a next-generation Industry 4.0 services portfolio to initiate, scale and sustain manufacturers’ transformation journeys effectively.

This transformation journey comprises three steps and starts with “Initiation”, in which TÜV SÜD assesses the readiness of production facilities to transform using best practice frameworks and tools. A key element is the Smart Industry Readiness Index (“Index”) which was launched by the Singapore Economic Development Board in partnership with TÜV SÜD last year. The “Index” provides companies with a structured and comprehensive approach towards understanding the current state of their manufacturing facilities and assesses their readiness for transformation in the context of Industry 4.0. To date, TÜV SÜD has completed more than 150 assessments with MNCs and SMEs across all industries.

After the initial assessment, TÜV SÜD partners with clients throughout their transformation, offering advice and guidance on how to fill specific gaps, Industry 4.0 roadmaps and business cases for technology implementation, as well as the relevant technical solutions to ensure safe and secure operations. One essential aspect for smart manufacturing is cyber security. Here, TÜV SÜD has set up a “Singapore Sealed Cloud” solution, powered by patented technology that ensures the highest levels of security and the uninterrupted operations of connected systems.

Unveiling the “Gateway to Industry 4.0”, a curated and immersive gallery powered by TÜV SÜD on the evolution and future of Industry 4.0 for ITAP attendees, he added: “As a global organisation furthering its roots in Singapore, we have always found the nation to be open to new ideas and experimentation, making it the perfect place to testbed solutions and industry frameworks. We look forward to partnering with our customers throughout their transformation journeys with our Industry 4.0 portfolio.” Through the Gateway, delegates can participate in a free self-assessment to evaluate their Industry 4.0 readiness and book an optional ten minute consultation with a TÜV SÜD expert to interpret the results.

TÜV SÜD’s Jackie Tan and Dr. Andreas Hauser will be speaking at the Future of Manufacturing Summit (17 October) and the Standards Forum (18 October) respectively. TÜV SÜD will also be showcasing the group’s comprehensive safety and security portfolio for Industry 4.0, additive manufacturing, cyber security and robotics at Singapore Expo hall 1 and 2, Booth F20. Live demos on Industrial Internet of Things (IIoT) will be conducted throughout the three days.

For more information, please contact TÜV SÜD at


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