Formlabs
formlabs
Formlabs has aligned with Medical Device Success Platform (MDSP) company Greenlight Guru in a bid to accelerate the development of medical devices.
By partnering, the two organisations aim to create a network of ‘information, expertise and technology’ to support medical device companies in the development of products while staying in compliance.
The Greenlight Guru platform provides users with document design controls and full traceability capabilities with integrated risk management. This platform will be paired with Formlabs’ pre-validated 3D printing hardware and sterilisable, biocompatible materials that are developed in an ISO 13485 facility.
Together, this joint offering is said to streamline design and development efforts, while maintaining compliance with biocompatible materials. With built-in QMS controls, it aligns with 21 CFR Part 820 and ISO 13485:2016, is also capable of supporting the auto compilation of design records and represents a ‘single source of truth’ for all product development, regulatory, quality and manufacturing processes. Formlabs and Greenlight Guru are also confident their partnership will ensure greater return-on-investment, as well as decreasing time-to-market.
“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,” commented Gaurav Manchanda, Director of Medical Market Development at Formlabs. “Dozens of commercialised medical devices, 250,000 surgical instruments and 70 million medical supplies have been printed with Formlabs technology to date. We are excited about this partnership leading to even more medical device innovation and novel tools that improve patient care.”
“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,” added David DeRam, CEO of Greenlight Guru. “Our partner programme is designed to educate and increase value for our customers by adding partners like Formlabs to our global ecosystem of industry relationships.”
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