Quality System Regulations
Current Good Manufacturing Practices CGMP regulations enforced by the FDA provide for systems to assure proper design, monitoring, and control of manufacturing processes and facilities. It is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce and distribute devices that meet the quality system requirements.
QMS Implementation Services
Sigma Biomedical assists manufacturers implementing and maintaining a Quality Management System that meets FDA requirements and complies with the ISO 13485 standard. Sigma provides the initial assessment and GAP analysis to determine compliance with regulations, develops an implementation plan, provides the necessary employee training, implements the QMS, and helps to audit and monitor the system so it is properly followed and continuously improved.
QMS Software Tool
In addition to Sigma's QMS implementation services, Sigma offers the QMS Tool, which is a customizable software and database system that helps manufacturers implement in electronic form document control, inventory control, manufacturing operation records, quality assurance records, customer interaction, device history records, purchasing controls and more. The system addresses all items specified in the ISO13485 standard, and provides reports and analytics of operations, provides product traceability and can be interfaced to Quickbooks and other accounting systems.
Sigma personnel counts with years of experience implementing, maintaining and providing training in Quality Management Systems in medical device companies for FDA compliance. Sigma expertise includes Design Controls, Product Development, Manufacturing and Distribution operations.
Sigma can assist manufacturers in implementing a custom QMS system appropriate and tuned to particular needs. Our product development experience along with regulatory expertise bring a great complement to small manufacturers who lack of onboard Quality and regulatory experts.
Products need to be developed and manufactured under good manufacturing practices. Sigma Biomedical assists companies in the implementation and compliance of their quality management systems
QMS TrainingQMS Implementation
Sigma provides the necessary training on Quality Systems Regulations so a compliant QMS can be implemented and followed by all employees. The training is customized to needs of manufacturers
QMS ToolSoftware System
Document, keep track and Improve your processes, procedures and forms in your QMS for regulatory compliance. The QMS Tool addresses all ISO 13485 requirements, and can be customized.
Regulatory AffairsRegulatory Affairs
FDA and International Regulations are complex and continuously evolving. Sigma Biomedical expertise takes the headache away and helps you stay in compliance with regulations