Quality Management System
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We offer the following services related to Quality Management Systems (QMS):
- Designated Management Representative for companies
- Daily operational quality guidance and support (Acting RA/QA VP role for companies)
- Design and implementation of full QMS
- Document Control
- Creation, management and retention of all quality records, including Design History File, internal audits, CAPAs, complaints, supplier qualification files, mfg. and inspection records, management reviews, design reviews, protocols & reports, recalls, MDRs, and post-market surveillance reports.
- Liaison with OEMs while representing QA on behalf of companies
Safety management
- CEC formation and management
- DSMB formation and management
- Interim report and final reports
Tracking systems
- Device accountability
- Complaints
- CAPAs
- Internal audits
- Supplier Corrective Actions
- Test Protocols and Reports
- MDRs and Post-market Surveillance Reports
- Recalls/Effectiveness Checks
Get started today by contacting Innoventz.
Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.
