Who We Are - Meet the Team and Careers
Our History
The CRO Group, Inc. based in Melrose, Massachusetts, a suburb of the metropolitan Boston area, was founded in 1996. Since the company’s inception, the founders have assembled a highly skilled development support, quality and regulatory team as well as established partnerships with other consulting organisations in medical device, consumer health care, and related industries.
Our Mission
We are committed to the satisfaction of our clients. We strive for the highest level of professionalism from our people. We are dedicated to providing value added choices and solutions for our clients where multiple development, quality, and regulatory paths exist. We operate ethically and within all applicable regulatory and standard requirements.
State of the Art
When it comes to tools, this isn’t The CRO Group’s first rodeo. We are familiar with all the latest tools in supporting and or managing your project – from Agile to Smartsheet, to Kanban Development, to JIRA, to Inspection and Audit Collaboration support via Slack, Zoom and Teams, The CRO Group staff are ready!
Senior Consultants
Our Senior Consultants have over 25 years experience, and specialize in supporting your design and development in IEC 60601-1 electromedical safety testing, IEC 62304 software development life cycle, ISO 14971 Risk Management, IEC 62366 Usability Engineering, ISO 13485, 21 CFR 820 and MDSAP QMS / Regulatory Audit preparations, as well as preparing 510(k)s, de Novo’s, and EU Technical File submissions.
Consultants
Our Consultants are equally strong in medical device design and development, software development, and quality system compliance and regulatory approvals. Most CRO Group Consultants have over 20 years experience preparing 510(k) submissions and international product registrations and have brought dozens of medical device manufacturers through the ISO 13485, CE Mark, and MDSAP certification process..
Associates
CRO Group Associates support our Consultants and our Clients for a wide range of projects – from setting up an ISO 13485 and QSR compliant QMS to coordinating and or monitoring a Clinical Study.
Careers at CRO Group
If you’re ready to join our team working with some of the leading as well as startup companies focused on tomorrow’s products in the aesthetic beauty, diagnostic, mobile medical apps, robotics, and wearables, we want to hear from you. The CRO Group offers a dynamic work environment and provides competitive compensation, benefits, and performance-based incentives.Quality/Regulatory Intern
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