Get the vital advantage
In our more than 45 years in medical device contract manufacturing, Donatelle has earned an impeccable track record helping companies develop innovative products and bring them to market, with the following advantages.
Absolute quality standards
Our company adheres to the industry’s highest standards and best practices. Based on successful experiences, our partners have come to expect the highest level of quality and innovation from us. In fact, we’ve set the standard of excellence – our facility is FDA registered and inspected with no Form 483 citations.
100% Medical Focus
As specialists focused exclusively on medical device design, development and manufacturing, our medical device contract manufacturing team offers an unparalleled understanding of our partners’ needs – including how to cost effectively meet the industry’s most stringent regulatory requirements.
With medical device engineering expertise ranging from cardiac rhythm management and cardiovascular surgery to drug delivery, spine and neuromodulation, we excel in helping our partners achieve their robust goals. And we specialize in intricate applications – like high-risk, long-term implants and disposables – where precision, tolerances, validation and timelines are critical.
Vertically integrated – all under one roof
Relying on a single-source from design through development and delivery helps optimize project communication, lead times and supply chain efficiencies.
Our medical device contract manufacturing team of tenured, highly qualified engineers, designers, machinists and toolmakers work together at our vertically integrated facility, which features controlled environments and ISO 7 (class 10,000) certified cleanrooms, as well as cleanroom production cells with integrated vision systems that can operate at ISO 5 (class 100) level.
Highest Overall Program Value
As experienced sourcing specialists will tell you, the cost of a program goes far beyond the quote. Our medical device contract manufacturing team works closely with our partners’ teams to identify significant savings opportunities from the start, through our Design for Manufacturing (DFM) process. We also achieve savings through efficient program management, consolidated resources, lean initiatives and tool management.
Plus, we’ve earned – and maintain – an impeccable track record of meeting product development deadlines, and more than 99 percent on-time delivery rate.
We understand how important a consistent and secure supply chain is to our partners, and to our own business goals. That’s why for decades we’ve proactively managed for growth and stability – and thrived. We manage our finances prudently and conservatively to be sure we continue to endure. We also provide a fulfilling work environment to attract and retain the industry’s most qualified talent. Plus, we embrace and invest in learning and technology to stay abreast – and ahead – of industry best practices, regulations and emerging technologies.