“We are experts at all aspects of regulation and compliance when it comes to medical device design, medical device product development and medical contract manufacturing, said Leo Carayannopoulos, President of Resolution Development. “We know how to make sure that all aspects of medical device product development design and manufacture are in compliance throughout the development life cycle.”
As such, Resolution Development knows how to work under the strictures of the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 as well as the International Organization for Standards 13485/2003.
“We start by developing design history files and device master records,” Carayannopoulos explained. “These can be based on the client’s quality management system and standard procedures or our own,” he explained.
For more information about Resolution Development medical device design, medical device product development, and medical device contract manufacturing and how they can help you drive medical regulations and compliance, visit, http://www.resolutiondev.com.
About Resolution Development
Resolution Development is a medical device product development company specializing in design, rapid prototyping and design transfer to manufacturing for the medical device, life sciences and automation industries. For twenty years, OEMs have turned to Resolution Development, knowing they have the skills and technical expertise to ready a product for manufacturing. The results are controlled cost of goods and reduced downtime. For more information, visit http://www.resolutiondev.com.
Gary C. Dionne
Gary C. Dionne