Quality Management System

Resolution takes quality seriously.  Our quality management system has passed audits by Fortune 500 companies. In many cases, our quality management system was selected by Fortune 500 companies for the development of Class II and Class III medical devices. our development capabilities include 13485 compliant product development, 60601 compliant product development, 62304 compliant product development. Our industry-leading quality management system was designed for medical device development services.

Resolution complies with the process controls required under the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Organization for Standards 13485. As a product development firm with success in medical device development services, Resolution creates all elements for the Design History Files and Device Master Records following our clients’ or Resolution’s quality management system and standard operating procedures.

Resolution develops products to comply with several industry standards such as UL, CE, IEC 60601, IEC 62304, ISO 13485. Our ability to deliver 13485 compliant product development, 60601 compliant product development, 62304 compliant product development services as part of our quality management system makes Resolution the best choice for medical device development services.

Risk Management

Resolution works closely with our clients to establish design and development plans to ensure that the program complies throughout the product development life cycle.  By working closely with our clients, Resolution fosters a team environment that allows us to efficiently drive to and document decisions, generate customer and product requirements, and generate the required risk analysis, FMEAs, and Hazard Analysis required to develop and to launch safe and effective medical devices.