We help you get more from your medical devices
Commitment to Quality
Bernoulli’s mission is to manufacture products and provide services that reflect the highest quality and reliability through a commitment to trust, integrity, respect and the pursuit of customer excellence. Our quality management system uses industry-recognized best practices to ensure customer satisfaction and compliance with applicable regulatory agency requirements, and is focused on preventing rather than reacting to quality defects.
Since 1989 we have been dedicated to developing and marketing products that meet or exceed customer expectations. We are continually improving the effectiveness of our quality management system while conforming to the requirements of ISO 13485, the EC Directive 93/42/EEC, CMDCAS and MDD Annex II. We emphasize the contribution that employees make to quality and excellence and work with them to provide the necessary information, training and support to enable them to achieve the required levels of proficiency. It is every employee’s responsibility to ensure the integrity of our quality system.
Bernoulli participates and adheres to national and international standards regulated by the FDA, AAMI, HL7 standards group and ISO. We also participate in clinical groups that are leading innovation in medical-based technologies such as Society for Technology & Anesthesia, Society of Critical Care Medicine, National Patient Safety Foundation (NPSF), the Institute for Healthcare Improvements (IHI) National Forum on Quality Improvement in Health Care, CHIME and HIMSS.
Click here to learn more about Bernoulli’s participation in industry groups and events.
Bernoulli has gone through a rigorous and comprehensive product innovation process with the Bernoulli One software platform that meets FDA regulatory approvals and compliance requirements for a Class II device. Learn more about our FDA 510(k) Class II Clearance>>
According to the FDA, an MDDS is precluded from use in active patient monitoring. Vendors whose solutions are intended for use in active patient monitoring are required to maintain FDA Class II status. Learn more about the MDDS Ruling>>
All Bernoulli employees are trained on Health Insurance Portability and Accountability Act (HIPAA) requirements and all service personnel are certified with Vendor Credential Services (VCS). All our quality procedures are maintained by a dedicated quality control department. If you have questions, please contact our service and support group.