Risk Management
Over the years PathWise has provided many of its diverse clients (with all their diverse needs) with support in Risk Management. So whether you are required by the FDA to have a common approach to Risk Management or need to conform to ISO standards 13485 or 14971, PathWise can show you the way.
Through our skills transfer workshop participants examine real on-the-job situations and leave with solutions. Allowing you to create a workforce that understands where risk originates, as well as how to prevent, mitigate, and document risk.
Some of the areas that PathWise has helped to address in Risk Management include:
- Understanding risk through the entire product life cycle
- Successful implementing tools for effective risk assessment and management
- Documenting and continuous review of the risk management plan
PathWise not only provides an outside perspective to these issues, we bring proven best-practices, tools, and processes. We’ve studied the best of the best in the life sciences field, and bring an intimate knowledge of the FDA regulation and ISO requirements.
Learn more about our solutions for Medical Device or Pharmaceutical companies.
Pharmaceutical
Developing a systematic approach to cGMP compliance isn’t easy. PathWise provides tools, systems, and best practices to simplify regulatory compliance for Pharmaceutical companies.
Medical Devices
The Quality System, QSR, presents a layer of complexity for many Medical Device companies. PathWise has the experience in helping to manage your quality systems that meet the challenges of regulatory compliance for Medical Device companies.
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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