Quality Management Systems, Good Manufacturing Practices, Quality Systems Regulations, ISO 13485

Quality Management
Good Manufacturing Practices

Quality System Regulations

Manufacturers must ensure quality in their products whilst meeting customer requirements and specifications. This is only achievable in a consistent way when a Quality Management System QMS is implemented and followed. Lacking quality in the products and business operations translates into customer complaints, increased rate of returns, business losses and have legal implications risking the overall business operation. However, implementing a QMS improves organizational effectiveness, customer satisfaction, increases compliance to regulations, organizational culture and improves documentation and workflow.

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.

Our expertise

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.

Quality Management


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 Training

QMS 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 Tool

Software 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 Affairs

Regulatory 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