Arena Solutions and MEDIcept Announce Partnership to Improve Compliance for Medical Device Manufacturers
Foster City, Calif., December 3, 2020 – Arena, the leading provider of cloud-based product development solutions for high tech, consumer electronics, and medical device industries, today announced a new partnership with MEDIcept, Inc., a leading international medical device and IVD compliance consulting firm.
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. “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 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.”
Arena helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit ArenaSolutions.com.
MEDIcept, Inc. is an international medical device and IVD compliance consulting firm. For over 20 years, we have assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, and Clinical services. Our staff includes experienced FDA, ISO, and industry experts who work efficiently to develop and maintain compliance through Quality Systems, regulatory strategies, clinical trials, remediations and other services. MEDIcept will help navigate the complex FDA and international regulatory pathways, reduce business risk, and increase time-to-market while maximizing the potential for success.