This partnership combines Arena’s leading quality management system (QMS) solutions with complementary quality management, regulatory, and engineering support from MEDIcept. Arena QMS customers already accelerate software validation using Arena Validate. Now, these same companies can leverage a team with decades of medical device industry experience to assist with validation testing, collaborate on regulatory strategy and compliance, and address quality assurance requirements.
“Arena QMS and Validate have provided medical device customers with a better way to manage their product and quality processes while adhering to FDA, ISO, and EMA quality system regulations,” said Craig Livingston, CEO for Arena Solutions. “With MEDIcept’s proven team and consulting services, medical device companies can shorten the time required to get products to market and meet critical compliance mandates.”
“In business, it’s all about relationships. MEDIcept partners with companies like Arena Solutions to provide greater value to companies in the medical device and life sciences market,” said David Rothkopf, President at MEDIcept. “This new relationship with Arena will provide regulated companies with a trustworthy and streamlined quality management system. This will help pre-revenue companies rapidly develop products and quality systems, and more mature companies evolve by meeting their product and regulatory requirements with an easy-to-use QMS system.”
