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ELC CONSULTING SERVICES |
SERVICES
CONSULTING AND SUPPORT
Quality Management Systems – establish, quality
manual, correct and maintain Quality Review
and gap analysis Internal Audits
Inspectional readiness review and plan
Devotions, Investigations and root cause
analyses/ identification Risk assessment
Equipment and facilities – design and maintain
Validation (equipment, process, cleaning and methods)
Notified Body – readiness for ISO 13485 and CE mark
Training – group and personal
Vendor Qualification – 3rd party audits