ISO 14971 Risk Management
ISO 14971:2007 is the current international standard for risk management for medical devices. It is recognized by the U.S., European Union, and Canada as a mean to establish, document and maintain a risk management program that complies with FDA, EU and Health Canada requirements.
Integrating risk management into your quality system can be challenging but is an integral part of design and development process. Risks need to be addressed throughout the entire medical device product lifecycle, whether you’re handling complaints, taking corrective and/or preventive actions or selecting suppliers.
Blue Skies can help you to assess your current level of compliance and design, and implement a risk management program that will allow you to monitor and manage risk at all stages.
Sarbanes-Oxley compliance
Public companies must comply with the financial disclosure and internal control requirements of the Sarbanes-Oxley Act of 2002 and related Securities and Exchange Commission (SEC) rules.
Blue Skies can help companies with their compliance needs as well as guide audit committees and boards of directors with establishing appropriate corporate governance procedures through internal controls documentation and evaluation services. We document the internal control environment, test and evaluate control effectiveness, assess risks and recommend a plan for improvement and continuous monitoring.
