Medical Devices
The QSR’s present challenges for many Medical Device companies. More than 100 warning letters are issued by the FDA each year, and thousands of 483 Observations are issued for resolution.
These issues can be problematic to resolve, due either to expertise or time constraints. PathWise has the experience in proving tools, systems, and methodologies for managing your quality system that meets the challenges of regulatory compliance.
Our solutions vary from client to client. But our commitment to transferring our knowledge of best practices and tools remains constant. Typical solutions consist of one or more of the following:
- Training – Our experts will simplify concepts, systems, and processes. Whether the topic you need help with is CAPA, Design Control, Risk Management, or something else, the methodologies we teach are used by 3 of the top 5 Fortune 500 medical device manufacturers.
- Consulting – Provides an intimate setting for us to work with your key personnel. Based on the issues you face, we’ll assign an expert to assist your team in solving your core issues.
> View Our Available Training Courses
Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.
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