RookQS and Grasp Health Forge Dynamic Partnership

Revolutionizing Global Medical Device Engineering Development Services

Rook Quality Systems (RookQS), a forefront provider of quality and regulatory solutions, proudly announces its strategic collaboration with Grasp Health, a recognized medical device development and manufacturing firm catering to clients worldwide.

Grasp Health, an expert in navigating the APAC medtech innovation ecosystem, is well-positioned to deliver engineering solutions for medical device manufacturers who seek rapid engineering iterations and mass production opportunities. Their proficient team, consisting of rapid prototyping, engineering, manufacturing, and clinical validation professionals, provides comprehensive support throughout the entire product lifecycle, from conceptualization to large-scale production. Boasting bilingual and bicultural engineering and product development experts, Grasp Health specializes in forming the right partnerships to facilitate your engineering development and clinical validation endeavors locally in the APAC region to support your US or EU regulatory submissions.

With a mission to breathe life into medical device concepts, Grasp Health possesses the expertise and resources to turn ideas into high-quality, innovative solutions, guiding medical device startups from project initiation to commercialization readiness. Grasp Health supports diverse medical devices, including intravascular devices, sterile disposables, microelectromechanical-based wearable systems, and medical imaging applications, etc.

Grasp Health extends a spectrum of services, encompassing proof of concepts, design and development, pre-clinical validation planning and execution, verification planning and execution, clinical validation planning and execution, design transfer, and mass production. RookQS is proud to support clientele at Grasp Health with regulatory strategy, pre-submission preparation, 510K clearance or PMA/De Novo approval, and QMS establishment and maintenance.

Grasp Health plans to receive ISO 13485 certification by Q3 2024 and ISO 27001 certification by Q4 2024. Grasp Health is headquartered in Taiwan and plans to establish its North American office in the Los Angeles area in 2024.

For those seeking support in bringing their medical device concepts to fruition or harnessing the insights of true subject matter experts, Grasp Health invites you to connect with them. Inquiries can be directed to info@grasp-health-ai.com; additional information is available at www.grasp-health-ai.com.