Class 7 Cleanroom
Injection molding and assembly services that adhere to the strict requirements of particulate-free(10K) manufacturing for medical devices.
When compliance is an issue and clean room manufacturing is required, Model Solution offers injection molding and assembly services in a medically optimized facility that has an ISO 13485 certified and FDA Facility (3009803802) registered. Our cleanroom guarantees a particulate-free process so we can create particulate-free parts.
The Model Solution facility is temperature and humidity controlled and is equipped with a positive airflow system for a contaminant-free facility. We also offer the value-added services of cleansing, packaging, and assembly within the clean room to ensure delivery of perfectly molded and packaged parts.
Model Solution’s success is based on our continuous efforts and dedication to the pursuit of quality. Our ISO certifications demonstrate our commitment to quality management, and continuous process improvement.
The ISO 9001 quality management systems standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, process approach and continual improvement. Commitment to ISO 9001 procedures helps ensure that customers receive consistent, high quality products and services.
ISO 13485 (FDA Facility Registration Number 3009803802)
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
The ISO 14001 standard specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. The standard is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability. ISO 14001 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties.
The ISO 27001 certificate ensures a high standard of securing all confidential information as specified in Information Security Management System requirements.