ISO 13485 Solutions for Life Sciences
PathWise provides ISO 13485 and other Quality Systems training and consulting for FDA and ISO regulated industries. Over more than a decade, we have provided best-practices for QSR’s, cGMP’s, CAPA, ISO 14971, ISO13485, and other issues impacting the Life Sciences industry.
Whether you’re facing an FDA warning letter, an uphill battle against the findings of a recent Audit, or wanting to improve quality and compliance, PathWise can help.
Our CAPA solutions help companies to understand the differences, similarities, and synergies between international industry standards and regulations such as ANSI/AAMI/ISO 13485:2003 and the FDA Quality System regulation.
We’ve worked with many companies in the Medical Device and Pharmaceutical device industries to solve problems such as:
- Harmonizing adherence to ISO and FDA regulations
- Understanding and procedurlizing the differences in regulation
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 13485 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.
© 2008 Pathwise - All Rights Reserved