Ambit BST and Greenlight Guru join forces to transform Quality Management Solutions (QMS) for Medical Device Companies

Ambit BST, a leading life sciences consultancy specializing in Pharma & Biotech, Digital Solutions, and Medical Devices, is excited to announce a partnership with Greenlight Guru, the industry's premier cloud-based electronic quality management system (eQMS) platform purpose-built for MedTech companies, fully compliant and validated. This partnership aims to transform quality management systems for medical device companies and empower them to bring life-changing products to market faster and with unwavering quality.

Greenlight Guru's end-to-end solution has already been recognized for streamlining product development, quality management, and clinical data management for MedTech organizations. By integrating cross-functional teams, processes, and data throughout the entire product lifecycle, Greenlight Guru empowers medical device manufacturers to replace their disjointed, legacy tools and achieve their regulatory and product development objectives in a rapidly evolving landscape.

The collaboration between Ambit BST and Greenlight Guru aims to digitize the quality management system for medical device companies. Drawing upon Ambit BST's life sciences expertise and Greenlight Guru's platform, the innovative architecture will empower medical device manufacturers to enhance the efficiency of regulatory and compliance procedures and facilitate companies in reaching their desired go-to-market goals rapidly. Ambit BST's consultants will provide expertise during the implementation according to the applicable standards and regulations, aiding companies seeking ISO 13485 certification to achieve their objectives and obtain the CE mark for Europe, LATAM or other registrations...

"We are thrilled to partner with Greenlight Guru to drive positive health outcomes globally," said Brismark Antoniony, Managing Director & Shareholder of Ambit BST. "This collaboration signifies a shared commitment to advance medical device quality management and enhance the quality of life for patients by delivering high-quality, safe, and innovative medical devices to the market."

"Through this technology collaboration with Ambit BST, we aim to accelerate the pace of medical device innovation and improve the overall quality management process," said Pete Plotas, Global Vice President of Alliances at Greenlight Guru. "Our goal is to support medical device companies in their mission to make a meaningful impact on patients' lives, and together with Ambit BST, we are making that vision a reality."

Ambit BST will be providing technical support in Spanish during the implementation phase. This addition ensures that Spanish-speaking markets can fully leverage the opportunities presented by this collaboration. Beyond the advancements in eQMS, this collaboration extends its benefits to encompass Greenlight Guru's Clinical and Educational solutions. This initiative aims to enhance accessibility and maximize the value of these innovative solutions within the Spanish-speaking life sciences landscape.

About Ambit BST:

Ambit BST is a leading life sciences consultancy with more than 20 years of expertise, known for its expertise in Pharma & Biotech, Digital Solutions and Medical Devices. Ambit BST guarantees the digitization of the life sciences industry conforming with quality standards and market regulations, with a team of industry experts and passion for innovation. The company helps clients navigate the complexities of the life sciences landscape through expert consultants and drive meaningful impact in healthcare. For more information, please visit www.ambit-bst.com.

About Greenlight Guru:

Greenlight Guru provides the leading cloud-based solutions for MedTech companies to bring life-changing products to people faster, and with less risk. Greenlight Guru provides purpose-built quality management, product development, and clinical data management solutions that together help teams accelerate timelines, streamline compliance, and deliver high-quality products. With Greenlight Guru, companies across the globe are improving efficiency, speed, and quality in every aspect of their organization to get products to market faster and keep them on the market longer. For more information, visit www.greenlight.guru.