Our Services
Our Services
Quality Services
ISO 9001 Quality Management Systems are regulatory requirements applicable to any organization to design and implement a quality management system. These standards require an organization to identify, document, implement, monitor/measure, and continually improve the effectiveness of its processes.
ISO 13485 Medical Devices Quality Management Systems, EU Medical Device Regulation, MDSAP & 21CFR820 are regulatory requirements specifically for the design and development, manufacturing, assembly, installation and servicing of medical devices – including the design, development, and provision of related services or component parts.
What We Offer For You
Quality Management Systems Development
Project & Process Consulting
Supplier/Vendor Evaluation
Documentation Development & Refinement
Quality System Auditing
Pre-Assessments (Mock Surveys)
Business Process Mapping and
Re-engineering
Standards and Regulatory Requirements Training
Assessment of Organizational Performance
Temporary or Interim Business Continuity Services
Standards and Regulatory Requirements Training
In addition to an initial system assessment, the client will work with the consultant to implement the standard and be prepared for initial certification or accreditation.
Assessment of Organizational Performance
Consists of a "practice" audit against the selected standards or requirements. The pre-assessment activity is an opportunity to coach the client on auditing practices and questions to expect during the actual regulatory audit.