REGULATIONS

 

We are proficient at complying with regulations and achieving relevant quality standards. That includes:

• ISO 9001:2015 - this standard is for quality management systems. It is used by organizations in a variety of industries to ensure that they are meeting the needs of their customers and stakeholders.
• ISO 13485:2016 - this standard is for medical devices. It is used by manufacturers of medical devices to ensure that their products are safe and effective.
• ISO 31000:2018 - risk management guidelines
• IEEE 1012:2016 - standard for software verification and validation
• ISO/IEC/IEEE 16085:2021 - systems and software engineering lifecycle processes, risk management
• IEEE/ISO/IEC 12207:2017 - systems and software engineering, software, life cycle processes
• FDA 21 CFR Part 820 - this regulation is for medical devices. It sets forth requirements for the quality systems used by manufacturers of medical devices.
• EN 14971:2019 - this standard is for risk management. It is used by organizations to identify, assess, and control risks to their products and services.
• 21 CFR Part 11 - this electronic signatures regulation sets forth the FDA criteria for consideration of electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to handwritten signatures executed on paper.