Medical Device Partner Ecosystem

Our Partners. Your Team.

Galen Data’s Medical Device Partner Ecosystem brings together expertise to meet a wide range of medical device company needs. Our relationships with these leading organizations create a comprehensive suite of proficiencies to contribute to your success.

Explore joint blog articles, podcasts, and webinars with our ecosystem partners, and contact them directly.

Featured Partner

Rook Quality Systems is a Quality Consulting Firm specializing in quality and regulatory strategy for emerging medical device companies. We work closely with your team to help get your device to market, faster. Our vision is to enable clients to implement compliant quality management systems (QMSs) to efficiently produce effective and reliable medical devices. 

We provide the tools to comply with domestic and international regulations, and offer expertise in FDA regulation, MDSAL audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices, including Class I–III, SaMD, and IVDs.

Glass Half Full Approach  |  Patients First  |  Being Proactive, Not Reactive

Contract Manufacturing

Global full-service contract manufacturer 

Ensuring medical device contract manufacturing success
Two-minute tour showcasing the benefits of a Valtronic relationship

Contract Research Organization (CRO)

Proxima works with the new class of rising stars in drugs, diagnostics, devices and digital health. They help emerging companies overcome regulatory and clinical obstacles to get their medical product approved.

Data Analytics

Extend operations with telemedicine and AI/Machine Learning for medical diagnostics

Experts in building and deploying AI/ML platforms for medical devices and clinical applications

Analytics and machine learning to enhance digital health

Design & Development

Design and development, test and evaluation, support and regulatory

Velentium specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. We have experience working with all sizes of clients, ranging from startups seeking seed funding to established Fortune 500 companies.

Cybersecurity design considerations for medical devices

Industry Connections

Insightful podcasts featuring leading experts in the medical device industry, sharing their success stories, advice, pitfalls, trends, and more for innovators in the MedTech industry.

Key issues companies face connecting their medtech to the cloud.

Quality, Regulatory, Compliance

Greenlight Guru is the only Quality Management Software designed specifically for the medical device industry.

Importance of software requirements in product development
Design controls, development, and risk for Software as a Medical Device (SAMD)
Strategies for improving medical device software and cybersecurity
Design considerations to maximize medical device cloud connectivity
How successful medical device companies de-risk post-market surveillance

Meet the challenges of new product approvals, identifying and correcting regulatory deficiencies, improving operational systems

Pathways for successful medical device quality audits
Tips for a successful quality audit

Specializing in quality and regulatory strategy including compliant quality management systems, FDA regulation, MDSAL audits, ISO 13485:2016 compliance, and MDR conformity for Class I–III, SaMD, and IVD devices.

New Cybersecurity Requirements for MDR

Sensor Platforms

Empowering the remote patient monitoring revolution with the Bravo1 patch, featuring continuous monitoring and “Edge to Cloud” machine learning capabilities

Sensor platforms, cloud connectivity, and the new medical dev​ice ecosystem

Software Development

Creating intuitive, custom Life Sciences solutions to assist medical device engineers, surgeons and clinicians for robotics, portables and wearables