Quality Services
Quality Audits
Thorough assessments to identify gaps and improve your quality systems efficiently.
Can perform internal and supplier quality system audits, either onsite or remote.
Design Documentation Audits (Design Files)
Quality Management Systems
Creation and improvement of quality management systems to be compliant with ISO 13485:2016 and ISO 9001:2015
Documentation of Quality Plans for QMSR Implementation or any other significant changes.
Perform onsite or remote training on a variety of quality topics
Experienced Speaker at multiple ASQ Conferences, including World Quality Conference (WCQI), Audit Division and Medical Device Division
Training/Speaker
Projects
Creation of Process Validations, Product Master Validation Plans, and Medical Device Files
Statistical Analysis using Hypothesis Testing and Other Statistical Tools
Cleanroom Validations and Establishment of Monitoring Systems
Risk Analysis including pFMEAs, dFMEAs, and uFMEAs
Design of Usability Studies
Process Mapping
Use of Quality Tools for Problem Solving
