What We Offer
REGULATORY AFFAIRS
We offer the Right Path, Right Now® to expedite your products faster to the global marketplace with maximum regulatory efficiency to avoid regulatory hurdles.
QUALITY MANAGEMENT SYSTEMS (QMS)
We offer the Right Path, Right Now® to develop, implement and sustain your Quality Management System for compliance to global regulatory requirements.
DESIGN QUALITY ASSURANCE
We offer the Right Path, Right Now® to define global regulatory and customer requirements to ensure compliant products and patient safety.
QUALITY ASSURANCE
We offer the Right Path, Right Now® to ensure all the planned and systematic activities are implemented within the quality management system to provide confidence in a quality product or service.
POST MARKET SURVEILLANCE (PMS)
We offer the Right Path, Right Now® to ensure a collection of processes and activities to monitor the performance of a product.
REMEDIATION ACTIVITIES
We offer the Right Path, Right Now® to ensure a quality plan to define remediation activities, root causes, and corrective actions as well as risk during remediation activity.
CONTINUOUS IMPROVEMENT
We offer the Right Path, Right Now® to reduce waste, increase efficiency, and improve internal employee and external customer satisfaction.
SAFETY
We offer the Right Path, Right Now® to develop and implement policies, ensuring that procedures are in place for the safety and health of employees within a workplace.
Meet Our Path Leaders
Latest News and Events
Advice from Experts on Getting Your Start Up Medical Device on the Path to Success
As a new medical device start up, the process of making your product compliant might seem daunting, but it doesn’t have to be. The experts in the field have some solid advice for getting on the right path. “A key piece of advice would be to have a strong regulatory strategy from the beginning as […]
FDA announces final guidance and upcoming webinar on Medical Device Reporting for Manufacturers
Today, the FDA issued final guidance on Medical Device Reporting for Manufacturers. This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act first described them and the Medical […]
CDRH Industry: The FDA Launches New Webpage for Reporting Allegations of Regulatory Misconduct
Today the FDA launched a webpage on Allegations of Regulatory Misconduct, which are claims that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. The website explains the process for submitting allegations to the Center for Devices and Radiological Health (CDRH) and contains a form to […]