Formlabs and Greenlight Guru Partner to Accelerate Product Development

Formlabs announces its partnership with Greenlight Guru, pioneer of a Medical Device Success Platform (MDSP), to accelerate the delivery of medical devices. Through this partnership, these two brands will create a supportive network of information, expertise and technology for medical device companies that will educate and provide services to accelerate medical device product development efforts while staying in compliance.

Greenlight Guru’s quality and product development platform enables teams to document design controls and automatically maintain full traceability with integrated risk management. The two organizations aim to streamline the development process by leveraging Formlabs’ pre-validated 3D printing hardware and materials paired with the use of Greenlight Gurus’s purpose-built quality management system. Formlabs users can leverage its range of biocompatible, sterilizable materials that are made in an ISO 13485 certified facility, and receive an exclusive offer from Greenlight Guru’s validated and fully-traceable platform to ensure compliance from design to development to production.

“This alliance enables medical device companies to seamlessly establish their quality system and maintain compliance while using additive manufacturing to produce a wide range of medical devices,” says Gaurav Manchanda, director of medical market development at Formlabs. “Dozens of commercialized medical devices, 250,000 surgical instruments, and 70 million medical supplies have been printed with Formlabs technology to date.” 

The joint offering will help organizations:

• Streamline design and development efforts with Formlabs’ 3D printing solutions for cost-effective design iterations and Greenlight Guru’s multi-level traceability matrix and integrated risk management.
• Maintain compliance with biocompatible materials made in U.S.-based, FDA-registered, ISO 13485 certified facilities and a solution with built-in QMS controls that align with 21 CFR Part 820 and ISO 13485:2016.
• Increase return-on-investment with quality and accuracy throughout development through high-accuracy printers and a quality system that supports auto compilation of design records. 
• Decrease time to market and accelerate scaling from prototype to production with a single printing platform alongside leveraging a single source of truth for all product development, regulatory, quality, and manufacturing processes. 

“Our partnership with Formlabs introduces our customers to emerging, innovative 3D printing technology that can further accelerate their time to market while cutting costs during research and development without compromising quality,” says David DeRam, CEO of Greenlight Guru. 

For more information about this partnership, visit www.greenlight.guru/formlabs. 

Sources: Press materials received from the company and additional information gleaned from the company’s website.