Certification of biomedical devices
Our biocompatible 3D resins have been specifically designed to fully comply with the Quality requirements for the manufacturing of medical devices (Class I, IIa, IIb and III of ISO13485).
Nevertheless, 3D resins manufacturers supply photoreactive photopolymer 3D resins, not biomedical devices, consequently their certification as suppliers of medical devices is not legally required nor justified and nor needed.
Photopolymer 3D resins are liquid photoreactive raw materials, which photopolymerise or react with light in the printers, need to be postcured and postprocessed properly to ensure that they are fully cured, safe and clean, "free of extractables, impurities and residuals", to make safe 3D printed biomedical devices.
Manufacturers of medical devices are legally responsible and liable for the quality and safety of their products and for manufacturing them in clean rooms under good manufacturing practices.
3Dresyns can consult you to select the safest 3D resins for each application and to design the safest products and post-processing protocols for ensuring maximum polymer conversion and minimum residuals and byproducts extractability by the body. Safety can only be ensured with proper radiometry controls of both the printer and the light box units as well as with well defined cleaning protocols to ensure that impurities and residuals are fully extracted before use, during the device postprocessing stage, and not during its use by the body (eg the mucous of the mouth in dental applications).
Safe and detailed printing, postcuring and postprocessing protocols are required to ensure that biomedical printed materials are safe for final users. In reality, consumers can be in risk of absorbing residuals and byproducts if the right radiometry and cleansing controls and protocols are not implemented by the manufacturers of biomedical devices.
Cutting corners by using third party photoreactive 3D resins "reactive raw materials" certifications, instead of certifying your products, will not cover your back since legally you will always be responsible of the quality and safety of your medical devices.
Consequently, reliance on "non meaningfull" third party certifications does not provide any legal coverage since the safety and quality of any 3D printed biomedical device legally depend on the device manufacturers, not on their raw materials suppliers...
Biomedical manufacturers are responsible of choosing safe photopolymer 3D resins, which can be identified by their hazards and risk phrases statements shown in their Material Safety Data Sheets MSDSs.
Biomedical manufacturers are responsible of working in clean rooms under good manufacturing practices , which include the elimination of residuals, impurities and byproducts of their biomedical devices.
3D resins as sold as are photoreactive resins, liquids, which are transformed to solids during the 3D printing process. Photoreactive liquid resins cannot be considered biomedical devices, despite some suppliers advertise as a marketing exercise their 3D resins as biomedical devices.
You should acknowledge that there is always some unreacted monomer, resin, reaction byproducts and photo accelerant and catalyst residuals trapped in the solid printed material (which elimination is beyond the control and competence of any 3D resin supplier), which need to be eliminated by the manufacturer to avoid its absorption by the skin and mucous of the body.
Well defined scientific protocols and processes need to be implemented to maximise health & safety.
We supply cost effective “safe” 3D resins and can support you to fully comply with FDA and ISO. We are the first and only supplier of monomer free resins in the market.
Our goal is to develop safer and safer 3D resins to help you make biocompatible devices.
We can consult you to get the Certification that you need, especially now with the incoming changes in the FDA and ISO, related to the manufacturing of medical devices.
We can support and consult you with the design of the safest work flow to ensure fully compliance for the future more and more deterrent regulations.
Please feel free to contact us to consult about our services and your goals at: info@3Dresyns.com