ECM Program Supports Entrepreneurial Innovation in the Medical Device Market
One of the most daunting challenges for startup entrepreneurs in the medical device industry is understanding the complex requirements to achieve regulatory compliance through the design, submission and post market stages. Anyone who does not meet the strict and multifaceted regulatory requirements throughout a product’s entire life-cycle faces the risk of not receiving the necessary approvals to sell their products. Furthermore, regulatory compliance is not just required prior to market approval. There are ongoing requirements that must be met to keep an approved device on the market. These requirements include reviews of product safety and efficacy as well as the quality management systems around the design and manufacturing processes.
Though all aspects of the medical device market are heavily regulated, the market is driven by innovation. Every year thousands of innovative and disruptive medical devices are brought to market.
How can young entrepreneurs navigate the tricky regulatory waters in order to bring their new life-saving devices to market? Startup entrepreneurs who have the drive to innovate and improve often lack the knowledge and tools necessary for quality management and regulatory compliance requirements.
ECM, a modern, agile Notified Body and leading innovator in helping bring medical devices to market quickly and efficiently will soon announce a unique solution to help medical device startups navigate the maze of regulatory compliance. Get in touch for additional details of how ECM will help market the next generation of medical devices through the new ‘CE Certification: Startup Project’.
ECM (Ente Certificazione Macchine) is a modern, agile, global Notified Body (NB) (#1282) and an accredited ISO 13485 Certification Body supporting European market access for medical devices and other products. Our team of professionals (comprised of over 65% of engineers) are dedicated to helping manufacturers bring safe, quality medical devices to global markets quickly, through ECM’s efficient testing and certification programs. As a modern NB, ECM rethinks the existing certification blueprints. We are defining new processes for regulatory approvals that will bring medical devices to the European markets faster.