As the developer of Class II and Class III technologies to improve patient experiences and outcomes, medical device product companies must meet rigorous standards such as UL, CE, IEC 60601, IEC 62304, ISO 13485 for their products. In addition, development must occur under a quality system with process controls such as those required under the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Organization for Standards 13485.
Whether the use of outsourced development partners is a small or large part of your overall research and development efforts, the partners you select must take regulatory compliance as seriously as you do. Often, outsourced development partners have limited experience with the deep levels of compliance and documentation required for the development of Class II or Class III medical devices. The lack of expertise may delay or stall the development process.
When selecting an outsourced development partner, medical device companies must look closely at the potential partner’s level of expertise with quality management and regulatory compliance. Does the partner have a quality management system (QMS)? Has that quality system ever passed an audit? Has it ever been the QMS used for the development project? What is their experience developing products that comply with IEC 60601 or IEC 62304?
An experienced development partner works closely with their clients to establish design and development plans to ensure that the program complies throughout the product development lifecycle. By working closely with clients, the partner can foster a team environment that allows efficient document decisions, comprehensive customer and product requirement development, and completed risk analysis, FMEAs, and Hazard Analysis required to develop and to launch safe and effective medical devices.
Resolution is uniquely qualified to support complex medical device development projects. With a deep understanding of key regulatory requirements such as IEC 60601, ISO 14971, ISO 13485, Resolution is able to develop products that can meet stringent regulatory requirements. 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.
Ensure your partner understands the unique requirements to develop a Class II or Class II medical device. Learn more about Resolution Developments Quality Certifications here.