AUGUST - 202019Apart from its testing services, clients utilize the diverse capabilities of EdgeOne in the product development lifecycle, including quality management, regulatory needs, remediation, and project management. Whether its developing regulatory strategy or quality solutions for unique business goals, the company effectively navigates its clients through the device development process. This enables the clients to engage with a single entity to fulfill all their needs rather than relying on multiple vendors. Lilli highlighted an instance where EdgeOne was engaged with a client for design control and testing of a combination product. The client then needed support on regulatory requirements and technical documentation for the European market. With the EdgeOne team's in-depth knowledge of European regulations, they were able to understand the context and seamlessly fulfill their additional needs. Being One-of-its-kind in the MarketLilli told us that most of the clients prefer EdgeOne Medical because they are independent of the product designers or any other workstreams involved. Without involvement and being invested in the design process, EdgeOne analyzes the product's performance adhering to the client requirements from a fresh perspective. The company's leadership is cross-trained from development to commercialization, ensuring that the design development documentation and product requirements are met. "We understand and respect the key players in the development process while importantly staying independent," Lilli stated. Given that the company understands the submission process and the performance requirements represented in the design control documentation, the test protocols are authored accordingly. "Testing is not just a transaction for us. When we perform testing, we connect all the dots from product, design and usability requirements through the testing process to assemble a complete story for the client which helps them be prepared for subsequent audits and reviews," explains Lilli. The secret behind EdgeOne's stellar ability to support clients is its consistent communication throughout the program. When assessing project scope, the company ensures the conversations address the requirements and issues/gaps within a project and then using their wide experience recommend how to achieve successful outcomes and make projects more efficient. During the program, the leadership from EdgeOne oversees the process and stays in touch with the clients to gain constant client feedback and incorporate any changes required. "These interactions extend our service beyond a project or program. We seek to develop a deep relationship with our clients, ensuring that the right people with skill sets are provided for their requirements," remarks Lilli. In addition to offering these technical services to clients, EdgeOne places great emphasis on its own culture. Further bolstering EdgeOne's strength is its strong team of domain experts and seasoned professionals. "We live and breathe our core values; this has been magnified now, especially in the COVID pandemic," adds Lilli. Response to COVID-19 and the Future AheadDuring the onset of the pandemic, where most organizations would have flustered to find a balance and take the step forward, EdgeOne's team effortlessly made adjustments to continue the programs and minimize the impact on the future pipeline of products. With admirable readiness, the company is currently actively engaged with projects to accelerate the development of COVID-19 diagnostic tests, therapeutic innovations, and maintaining support to the existing client programs. EdgeOne offers its support to help these solutions reach the market quicker and make an impact. Lilli observes that due to COVID-19, market forces are accelerating the development of connected health and digital health products that can be stand-alone devices or integrated into combination product platforms. EdgeOne, already providing its services in the digital health field for existing clients, looks forward to expanding further into that arena. The company has developed unique capabilities and expertise in-house to support digital health platforms from testing as well as design control and submission perspectives. Having carved a unique niche in the industry based upon Lilli's vision of the industry's need, EdgeOne continues to grow and stay ahead of the curve by providing skillsets in various technologies evolving in the market today and keeping pace with it. Moreover, EdgeOne plans to invest in expanded equipment capabilities and advanced technologies to bolster its testing services for combination products and medical devices. "We envision ourselves being a leader of contract development organizations that supports innovative technologies, not just the tried and true ones, but ones that are transformational as well," concludes Lilli. Our growth is an opportunity to serve our clients with more and better services"
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