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About Certifications and Quality Management Systems

Biomedical certifications of any photoreactive liquid 3D resins considering them as manufactured medical devices do not make much sense, nor provide any warranty, nor safety, nor biocompatibility assurance since photopolymer 3D resins are cytotoxic before and even after printing if not fully cured and "cleaned" with the right controls and protocols. 

As example, click here to discover these recent published findings about the toxicity of Formlabs Dental 3D resins even after being printed and postprocessed: 

Fig. 2

As clearly highlighted in the mentioned scientific paper published by the Northwestern University (Chicago, USA), Formlabs’ Dental SG and LT Clear printed in Form 2 SLA 3D printer were toxic, despite being certified as biomedical devices. 

Photopolymer 3D resins are liquid photoreactive raw materials, which photopolymerise or react with light in the printers in order to cure or become printed solid materials. They need to be postcured and postprocessed or "cleaned" properly to ensure that they are fully cured or free of extractable unreacted monomers.

Scientific protocols need to be designed and implemented properly to ensure that catalysts, byproducts, extractables, impurities and residuals are either fully trapped inside the medical device or eliminated or extracted before their use to reduce the potential risk of their extraction and absorption during their usage.

They need to be converted from a photoreactive liquid 3D resin into a fully cured and cleaned "safe" biomedical device.

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, acknowledge that 3D resins manufacturers supply photoreactive photopolymer 3D resins, not finished biomedical devices, consequently their certification as suppliers of medical devices is not applicable, nor legally necessary nor justified, despite it is a common "pure marketing" practice in industry.

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.

Certifications which do not take into account the control and monitoring of the light power of both the printer and the light box, nor the cleaning process in detail, cannot ensure that medical devices are safe for use. Just rinsing parts with isopropanol does not provide any warranty for the safety and readiness for use of any biomedical device.

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 human 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 extracted before use, during the device postprocessing stage, and not during its use by final users to avoid its potential absorption 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"certifications" of your raw materials suppliers, instead of certifying your medical devices and processes will not cover you legally since you will always be responsible of the quality and safety of the medical devices manufactured in your facilities.

Consequently, reliance on "non meaningful" certifications does not provide any legal coverage nor warranty since the safety and quality of any 3D printed biomedical device obviously legally relies on the device manufacturers, not on their raw materials suppliers.

Biomedical device manufacturers are responsible of choosing safe photopolymer 3D resins, which can be easily identified by their hazards and risk phrases statements shown in their Material Safety Data Sheets MSDSs. 

Biomedical device manufacturers are responsible of working with good manufacturing practices , which include the elimination of residuals, impurities and byproducts of their biomedical devices.

As clearly declared, 3D resins as sold are photoreactive liquid resins, which at least lowest effect may cause skin, eye and mucous irritancy. Consequently, any photoreactive liquid resin cannot be considered safe biomedical devices, despite some 3D resins suppliers advertise and market their 3D resins as biomedical devices. 

This marketing exercise is not only misleading but also creates confusion giving a false sense of security and legal security and coverage. 

You should acknowledge that there is always some unreacted monomer, resin, reaction byproducts and catalyst residuals trapped in the solid printed polymer material, which elimination is beyond the control and competence of any 3D resin supplier, that need to be either cured or removed and cleaned properly by the device manufacturer to avoid their later extraction by eg the saliva and their absorption thru eg the skin and/or mucous of the mouth.

Well defined scientific protocols and processes need to be implemented to maximise health & safety.

We can supply cost effective “safe” 3D resins, protocols and support to help you to fully comply with FDA and ISO. We are the first and only supplier of monomer free resins in the market. (without any monomer content as supplied) 

Our goal is to develop safer and safer 3D resins and processes to help you make safe 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 workflow and protcols 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

Related links:

Are medical device raw material suppliers required to be ISO 13485 certified?

About 3Dresyns certifications 

The different existing ISO can be easily implemented in traditional single product design but becomes not implementable in our multivariable and multifunctional 3Dresyns business approach since our 3Dresyns portfolio includes online custom ordering of complex multivariable and multifunctional products. Over 2000 colors and up to 4 functional additives among around 50 can be custom added and ordered online to over 300 3Dresyns for online custom design of ready to use of billions of materials choices.

The ISO 9000 family has a limited view with regards the handling of billions of materials choices!

Our multifunctional business approach and offering require innovative Quality Management Systems, which cannot be contemplated in the existing traditional management systems of ISO.

About our product identifiers: SKUs ?

SKU stands for “stock keeping unit” and as the name suggests, it is a number that it is assigned to identify and keep track of a distinct type of item for sale, such as a product or service, and all attributes or functionalities associated with the item type that distinguish it from other item types. For a product, these attributes can include manufacturer, description, material, size, color, functionality, packaging, etc.

Our 3Dresyns SKUs follow this basic descriptor scheme:

Single or unifunctional 3Dresyns SKUs: P+ number 

whereP stands for Product

Note:  we have already around 2000 SKU or single or unifunctional product references which can be converted automatically into billions of SKU by adding multifunctionality:

Multifunctional 3Dresyns SKUs: P + number + C + number + F + number/ number/number/number

where:

  • P stands for Product
  • C stands for Color: thousands of colors can be added
  • F stands for Functionality: up to four functionalities can be added

Our SKU calculating system is ideal for multivariable and multifunctional product identification since uses descriptors or identifiers.

SKUs will be written on the label of each ordered bottle and on your invoice

About Lot numbers?

Our lot numbers are also quite useful for product identification and tracking, since if ordered product has assigned an automatic Lot number. which is calculated as follows:

Lot number: Invoice number + one number eg 1,2,3..

  • number 1 for the first ordered product of the same order
  • number 2 for the second ordered product of the same order
  • number 3 for the third ordered product of the same order
  • ...

The Lot numbers will be written on the label of each ordered bottle and in your invoice

About our Expiration dates

The expiration dates of most of our products are also automatically calculated and reported with this basic principle:

  • Expiration date: Invoice or order date + 1 year

The expiration date will be written on the label of each ordered bottle and in your invoice

Certicate of Conformance

For each order you can request a Certificate of Conformance which will indicate that your ordered 3Dresyns have been manufactured following Resyner Technologies quality control procedures and standards.

On-site / off-site and second-party audits
A second-party audit is when a customer performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract. These requirements may include special control over certain processes, requirements on traceability, documentation, records, etc... In non sensitive businesses t
hese audits can be done on-line or even off-site by reviewing documents submitted by the supplier.

Our business model is an efficient multivariable & multifunctional online service, not a face-to-face showroom, designed to give fast and reliable online solutions to existing unmet customer and market needs related to 3D printing. 

3Dresyns customers are not allowed to perfom any on-site / off-site second-party audits since our confidential information, trade secrets, know how and facilities have restricted access to protect us and our key customers and to fully comply with existing NDAs and with our security policies.