REGULATORY AFFAIRS AND QUALITY ASSURANCE

Leverage Our Expertise for Your Quality & Regulatory Needs

Utilize the advice of our experienced RAQA team
Access reports, certifications, and master files
Accelerate time to market
Inspection/audit support, regulatory services, and quality system development from our RA team
Four clear 3D models

In-House Regulatory, Quality, and Medical Device Manufacturing Expertise

Utilize the expert knowledge of our RAQA team with 40+ years of experience, including dozens of successful 510(k)s.
Trust our resin manufacturing experience at a ISO 13485-certified, FDA-registered, US-based manufacturing facility, that has produced over 1 million liters of resin and 40+ proprietary materials. Formlabs Medical Device Resins are made in a certified ISO Class 8 Clean Room and registered with the FDA and CE marked according to the EU MDR.
Have confidence knowing that over 30,000 printers in healthcare settings have produced over 150 million end-use parts.
3D printed medical devices
Documentation
Formlabs Medical Device Standards, Statements, and Certifications
Clear 3D printed medical devices on top of a BioMed Flex 80A resin cartridge
Data Sheets
Access Technical and Safety Data Sheets for Formlabs Materials
Three resin cartridges and a Form 3B printer in a medical setting
White Paper
The Ultimate Guide to Quality Assurance and Regulatory Affairs in Medical 3D Printing
Person wearing gloves holding an anatomical model in front of a Form 3B 3D printer
White Paper
Formlabs Guide to SLA Quality Control Management for Healthcare Innovators

Calibration Documentation, FDA Master Files, and More

Hardware maintenance schedules and calibration documentation (IQ/OQ/PQ)
Lot numbers and Certificate of Conformance and Certificate of Analysis (COC/COA)
ISO 10993 and USP testing information
Access to FDA Master Files, ISO and USP certifications, and sterilization reports
Person holding custom surgical instrument

See Also

Form 4BL 3D printer
Webinar

FDA Master Files: Simplifying Pre-Market Submissions

3D printed medical devices and anatomical models
Webinar

What Is Biocompatibility and What Should It Mean to You? Hear From Nelson Labs

Two people in PPE holding a 3D printed skull
Regulatory Information
Learn About Regulations for Medical Models at the Point-Of-Care
3D printed insoles on blue background
Webinar

Medical 3D Printing Quality Management for Healthcare Innovators

3D printed parts in BioMed Flexible 80A Resin
Webinar
Formlabs x TÜV SÜD: Exploring Additive Manufacturing and Regulatory Requirements in the EU

Cleared, Commercialized Devices

Dozens of companies have received regulatory clearance for end-use devices printed with Formlabs’ materials including surgical instruments, orthopedic resection guides, orthognathic splints, sleep apnea devices, and more.
Formlabs has been validated in 510(k) cleared processes including medical imaging to sterilization.
Formlabs customers have received Emergency Use Authorizations, Compassionate Use Authorizations, MDR Article 5 exemptions, and 510(k)s.
3D printed nasal swabs in packaging

See Also

Clear anatomical model of the upper jaw and cheeks
Case Study
Techfit Achieves Fast, Under-Budget FDA Clearance With Help From Formlabs RAQA Team
Three people in operating room with an anatomical model
Webinar
3D Printed Medical Devices for Precision Surgery
Woman wearing eye protection and gloves removing a print from a printer
Case Study
How Formlabs Helps ImmersiveTouch Revolutionize Surgical Planning
Tools made with 3D printed parts
Case Study
The Next Generation of 3D Printed Surgical Instruments

A Full Suite of 3D Printing Solutions

Form 4B
A DESKTOP 3D PRINTER DESIGNED FOR HEALTHCARE

Form 4B

Produce functional, high-quality prototypes and end-use parts in record time. Supports biocompatible materials.

Parts requiring biocompatibility and sterilization
Medical device prototypes, jigs, fixtures, molds, and end-use parts
Visual aids for diagnosis and education
Models for diagnostic use in FDA-cleared workflows

Form 4L for Medical
BIG PARTS, BIG IDEAS

Form 4BL

Take control of large-scale part production, increase your throughput, and bring your biggest ideas to life.

Mid-size to large medical device prototypes
Molds and dies
Surgeon-specific or patient-specific objects
Full-size anatomical models for adult anatomy

Fuse 1+ 30W for Engineering
HIGHEST PERFORMANCE

Fuse 1+ 30W

Bring production-ready nylon 3D printing onto your benchtop with an affordable, compact selective laser sintering (SLS) platform.

Functional medical device prototypes
Complex medical parts printed without supports
End use parts: enclosures, connectors, manifolds, prosthetics, insoles
Long-lasting, durable jigs and fixtures

The Best Selection of Advanced Medical 3D Printing Materials

Choose between our wide range of proprietary materials, certified third-party materials from top-tier manufacturers, or experiment with any unvalidated 405nm photopolymer resin with Open Material License. Our library comprises over 45 materials, including a variety of biocompatible formulations and high-precision, durable materials for medical device manufacturing to fuel innovation in 3D printing medical applications. Formlabs biomedical and medical device resins are designed and manufactured within our robust Quality Management System that is ISO 13485 and EU MDR certified in our certified FDA Registered facility.

3d printed medical parts
Formlabs 3D Printers

Upgrade Your Medical Device Manufacturing Today

30,000 Formlabs printers in healthcare settings have produced over 150 million end-use parts. Explore our 3D printers to find the right solution for your business or contact a Formlabs Solution Specialist for a consultation.