How Formlabs Develops and Certifies Compliance for Over 25 Biocompatible Materials

Posted by FIT THAI on April 9, 2026

The Formlabs resin library includes BioMed Resins, which are medical-grade materials for a variety of applications where performance and biocompatibility are critically important, and Dental Resins for over 15 dental applications.

Formlabs' biocompatible materials are produced in-house at Spectra Photopolymers, a Formlabs facility registered with the FDA for material manufacturing, making Formlabs the first company to have a fully integrated approach to both 3D printing hardware and materials. Formlabs' global Regulatory Affairs and Quality Assurance (RAQA) team is responsible for global compliance for hardware, chemicals, medical devices, and environments, including the quality of Formlabs resins and international medical device registration.

Together, our team of experts has documented over twenty 510(k) submissions and regularly consults with customers to support regulatory approval submissions. Bradley Heil, global regulatory compliance leader, said, “Our team helps bring innovative products to market by ensuring those products meet the highest levels of safety and quality. This allows our customers to print more work in more places, and in healthcare, that means helping more patients.”

Read on to learn how Formlabs develops and manufactures biocompatible materials and how our team can help you bring medical devices to market.

Formlabs Materials Manufactured by Spectra Photopolymers

In 2018, Formlabs became the first company to have a fully integrated approach to both 3D printing hardware and materials after acquiring Spectra Photopolymers in Ohio. At Spectra, the RAQA team works to ensure that resin production meets the highest quality standards.

Medical Resin Production

BioMed Resins can be used in a variety of applications, including those requiring durability, flexibility, or transparency.

Formlabs produces Biomed and resins for medical devices at Spectra, a facility registered with the FDA. These materials are designed and manufactured under a rigorous quality management system, certified to ISO 13485 and EU MDR standards.

“A dedicated manufacturing team, supported by quality assurance experts, oversees, manages, controls, and inspects the production of Formlabs' medical and BioMed resins directly. This should give customers confidence that these materials meet the performance and quality standards as designed.”

Nathan Alt, Director of Regulatory Affairs and Quality Assurance, Formlabs

This dedicated team of operators and quality assurance experts produces resin within an ISO Class 8 certified cleanroom. All medical device resins are appropriately registered with the FDA and carry the CE mark per EU MDR requirements.


Resin production at Spectra, a Formlabs facility registered with the FDA	Resins undergo thorough testing throughout the development and production process.

Formlabs' strict adherence to RAQA standards means that resin production has undergone thorough scrutiny. “Our team at the facility ensures that all products are properly documented, and we have complete traceability throughout the process,” Heil said.

Global Biocompatible Materials

Spectra produces over thirty thousand liters of biocompatible resin annually. BioMed Resins are designed for healthcare professionals seeking medical-grade materials for a variety of applications, where performance, biocompatibility, and compatibility with sterilization and disinfection methods are critically important. What drives this is patient safety concerns, risk reduction, and assurance for healthcare professionals.

“Our customers can trust that the development and production of our resins have undergone rigorous scrutiny and are of the highest quality.”

Bradley Heil, Global Regulatory and Compliance Leader, Formlabs

Biocompatible resins include a set of Dental Resins that allow dental clinics and laboratories to quickly produce a variety of dental products in-house.
Heil stated, “During the development of our medical and dental materials, we take a risk-based approach based on the intended clinical use to address the risks associated with how customers may use our materials.” Additionally, “Experts on our quality and regulatory team have worked in biocompatibility testing laboratories and can ensure that all our resins meet the necessary requirements to pass biocompatibility testing.”

RAQA is integrated into the resin development process, as well as the needs of medical and dental professionals. For this purpose, dedicated quality engineers focus on quality control, labeling, and reviewing instructions for use (IFU). Other team members ensure that resins are tested to meet all necessary requirements for healthcare customers and regulatory agencies, including mechanical testing, biocompatibility testing, and sterilization. For BioMed resins, this also includes having an FDA master file available for customer use.

Although Spectra is located in the United States, Formlabs' RAQA team is a global team “responsible for bringing products to market worldwide, including registration with multiple health authorities,” Heil said. This includes transitioning medical device resins from MDD to MDR in Europe to ensure compliance across all continents.

Consulting with the RAQA Team

Many Formlabs customers are working to bring innovative products to market. Obtaining the necessary quality and regulatory approvals to do so can be a significant hurdle. Heil stated, “Our team is ready to consult and help make their dreams a reality. We have worked with several companies on their own regulatory approval submissions and celebrated successes when those products hit the market.”
“The work that our quality and regulatory team does can help reduce the workload that our customers have to do. By utilizing our data or the master file we hold with the FDA, our customers may not need to conduct their own biocompatibility testing of their devices, saving both time and costs in bringing products to market.”

Bradley Heil, Global Regulatory and Compliance Leader, Formlabs

The RAQA team works with companies that are in the process of seeking approvals from health authorities, providing information and documentation available in the system. Additionally, they have stepped in to help answer specific questions from regulators, from the FDA to Health Canada.

This intent to assist customers in managing regulatory and quality demands has helped medical device companies save both time and resources.

TechFit Digital Surgery received FDA approval for its new digital jaw surgery system in June 2023 after setting a goal of just 12 months for regulatory approval. By collaborating with Formlabs' RAQA team, they were able to achieve this in just 6 months. Mauricio Toro, co-founder and CEO of TechFit, stated, “Choosing the printing platform for 510(k) is a decision worth hundreds of thousands of dollars. Knowing that Formlabs has done that before gives you confidence in your decision.”

Revolutionizing Healthcare

“3D printing has the potential to revolutionize healthcare, whether through innovative new materials that enable new applications or the ability to print at the point of patient care. Formlabs offers both hardware and materials to make this possible.”

Bradley Heil, Global Regulatory and Compliance Leader, Formlabs

From professional 3D printers developed for healthcare to Biomed and resins for medical devices, Formlabs is committed to developing tools for medical device manufacturers. Biocompatible and sterilizable materials enable innovative research and development (R&D) and low-volume commercial production in-house for rapid iteration and timely production of parts.

A fully integrated approach means that Formlabs' RAQA team is involved in every step of the design, testing, and production of high-quality resins optimized for use with Formlabs' 3D resin printers. Controlling this entire process ensures the quality and consistency of the resins, while the detailed work of the RAQA team can help reduce the workload that medical device manufacturers have to do in bringing products to market.

To explore how Formlabs can help you achieve your printing goals in healthcare, talk to a 3D printing expert.