Experien Group provides comprehensive quality management system support to our clients. Our integrated approach covers all elements of companies’ quality assurance requirements. Our accredited staff members perform internal audits and supplier quality assessments for companies to ensure their compliance with requisite internal policies and external regulations. We also support clients throughout their preparation for FDA and State of California inspections as well as Notified Body audits.
Experien Group develops, reviews and/or refines clients’ quality management system documents to ensure that all relevant industry requirements are satisfied. In addition, we offer clients a fully customized, comprehensive Quality Management System for purchase. Companies may select individual procedures such as Design Control or Risk Management, or they may opt for a complete Quality Management System that includes a Quality Management System Manual, all requisite Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs), and all relevant forms.
 Experien Group’s Quality Management System exemplifies best-practice methodologies in the medical device field and is designed in accordance with all relevant international standards and FDA requirements, including:
- FDA’s CFR 21 Part 820 Quality System Regulation
- ISO 13485:2003 and ISO 14971:2007
- European Medical Device Directive – Council Directive 93/42/EEC
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