The different existing ISO can be easily implemented in traditional single unifunctional product design but becomes not easily implementable in our multivariable and multifunctional 3Dresyns business approach since our 3Dresyns portfolio includes online custom design and ordering of complex multiresponse made to order multivariable and multifunctional products.

Each of our nearly 500 unifunctional products has a basic SKU (Stock Keeping Unit) which can be converted online to over 10 billion products and SKUs, after online optional functionalization with thousands of colors and up to 4 functional additives, among around 50 choices.

All our made to order 3D resins, including the simplest unifunctional resins, need to be tuned by us for each printer specification for optimum printing, resolution, mechanical properties, and biocompatibility.

The ISO 9000 family has a limited view and applicability of predictive, interpolative, and corrective algorithmic systems based on artificial intelligence for choosing online billions of no previously existing made to order materials!

Our multifunctional multiresponse business approach and offering require innovative Quality Management Systems QMS, which cannot be easily covered by the existing traditional "one factor at a time" univariable "too rigid" ISO family management systems.

AI algoriths are already used in quality assurance for predictive analytics by leveraging historical data and machine learning algorithms for detecting defects and deviations in quality control. The use of AI algorithms are ideal for preventing quality problems, as well as for designing online new non previously existing products, whic can be created online with 3Dresyns multifunctional offering.

Unfortunately, right now, the online design of new produts, without the associated preexisting documentaiton and paperwork is non ISO compliant when applied to product development and commercialization.

Discover: 3Dresyns Quality Policy

About QMS and ISO

Of the existing 334 million companies in the World, only around 1 million are ISO certified, representing 0.3% of the total!

In this paper Are innovative organizational concepts enough for fostering innovation? is concluded that:

ISO 9000 negatively influences revenues from radically new products probable due to additional documentation that is needed for approval of this new product which then negatively influences revenues

ISO, DIN, ASTM, and other testing standards are ideal for testing the different properties of materials since they permit the comparison of standarized test results undertaken with certain standards, with the same testing conditions:

3Dresyns products are compliant with several regulations, such as the mentioned in the following links:

On the other hand, ISO QMS certification can limit the innovation of disruptive companies, since excessive paperwork and rigidity limits the innovation and the time to market of new ways based on AI algorith for online new product functionalization. 

3Dresyns as supplier of raw materials does not need to be certified for improving its processes and documenting their faults and errors while taking corrective and preventive measures to yield in higher quality of the offered services and products.

In practice, 3Dresyns QMS has similar principles to ISO 9001 but decided not to be certified for several reasons, such as reduce paperwok, increase flexibilty, reduce costs, etc.

What countries require ISO 13485 certification for medical device manufacturers? source

  • Europe – the MDR 2017/745 and ISO 13485:2016
  • UK – UK MDR 2002
  • Canada – CAN/CSA-ISO 13485:2016
  • USA – US Quality System Regulations (21 CFR 820), together with ISO 13485
  • Japan – ISO 13485
  • Australia – The Therapeutic Goods document requires ISO 13485:2016.
  • Singapore – ISO 13485
  • Malaysia – The Medical device act (Act 737) requires ISO 13485

In the rest of the Word ISO 13485 isn’t mandatory.

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

ISO 13485, ISO 9001, 21 CFR 820 or any other QMS standard/regulation worldwide do not require raw material suppliers, such as 3D resins, to be ISO13485 certified.Reference supportive publications:

3Dresyns Quality Assurance

3Dresyns performs appropriate quality controls to ensure that each lot is produced according to the specifications of the manufacturing recipe of each product reference.  3Dresyns QMS shares and implements similar processes to ISO where processes are continuously improved, tracked and revised to increase the quality of its services and products.

On-site / off-site and second-party ISO 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 these audits can be done on-line or even off-site by reviewing documents submitted by the supplier. Announced and unannounced audits are contemplated by ISO standards and performed on a supplier without first discussing the audit with the supplier or giving them prior knowledge of the inspection date. 

3Dresyns does not allow outsiders, such as suppliers and customers to visit, not to perfom any on-site / off-site second-party audits for security reasons, since 3Dresyns facilities have restricted access to prevent any potential risk of physical data breaches and fully comply with our existing NDAs and 3Dresyns physical and digital security policies. This high level security is particularly crucial to protect us and our customers.

If you as a customer have as requirement to be allowed to come on-site for an audit, you will need to accept our prohibition to access our facilities by outsiders.

3Dresyns business model is an efficient multivariable & multifunctional online company based on a multiresponse optimisation system (not a face-to-face public showroom or workshop) designed to sell online its products and services.

About certification of medical devices

3D printed medical devices fall within the scope of specific EU product legislation, such as the EU Medical Device Regulation MDR 2017/745. Therefore, manufacturers of medical devices must ensure that their 3D printed products meet the requirements of the applicable EU legislation, carry out the necessary conformity assessment procedures, compose a technical file, draft the EU declaration of conformity and affix the CE marking, before placing them on the EU market.

3D resins are raw materials, not finished medical devices

Photopolymer 3D resins are liquid photo reactive raw materials, which photopolymerise or react with light in the printers, normally layer by layer, to cure or become printed solid materials with specific shapes and functionalities to comply with the quality requirements of a broad range of biomedical devices and packaging, including dental, orthodontic, hearing, implant, prosthesis, food, and pharmaceutical devices and packaging.

Biocompatibility certifications of photoreactive liquid photopolymers "3D resins" considering them as medical and packaging devices are considered as "placing on the market unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner". For more info read: CE marking and Health & Safety concerns of "certified" 3Dresins

Production of products under ISO certification

Under contract, 3Dresyns can manufacture its products under the ISO family with its partner tollers, which are ISO certified to manufacture 3Dresyns products under ISO certification.

Reference supportive publications: