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6. Regulatory context
Despite the potential of additive manufacturing in the medical field, there are many regulatory and safety hurdles to overcome . In order to bring the product to market, the device must meet specific standards to ensure that it does not represent a risk to the patient . Standards are generally very strict, and have a direct impact on the global medical implant market.
Indeed, while...
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Regulatory context
Bibliography
Bibliography
Standards and norms
- D11 Committee: Test Method for Rubber Property – Durometer Hardness, ASTM International - ASTM - 2017
- Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56041), ASTM International - ASTM F136-08 - 2014
- Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants...
Regulations
EU 2017/745 – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (2017)
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
3D Systems – Laser melting machines on metal powder bed http://www.3dsystems.com/
Altair – Software for numerical simulation and topological optimization (SolidThinking Inspire ® )
Statistical and economic data
Gartner Predicts 2019 https://www.gartner.com/
International Data Corporation (IDC) http://www.idc.com/
Netscribes Inc. https://www.netscribes.com/
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The Ultimate Scientific and Technical Reference