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- Complaint Handling Procedures Bundle | ISO 13485 | FDA QSR Compliant
Complaint Handling Procedures Bundle | ISO 13485 | FDA QSR Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Includes All Related Forms
- MS Word Format
- Digital Content - Instant Download
Complaint Handling Procedure BundleThe Complaint Handling Procedure Bundle groups together a series of procedures related to the management of medical device complaints.
Complaint Handling Procedures OverviewThe Complaint Handling Procedure Bundle provides the procedures necessary to effectively log, manage, and response for all sources of complaints.
Complaint Handling Procedure Bundle ContentThe Complaint Handling Procedure Bundle includes the procedures listed below:
Complaint Handling Procedures ComplianceThe ISO 13485 Complaint Handling Procedures are ISO 13485:2016, FDA QSR and MDR EU 2017/745 Compliant.
For more information about our Complaint Handling Procedure Bundle please contact us at [email protected]
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Complaint Handling Bundle Contents |
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Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant
- Comprehensive Complaint Data Capture Form
- Includes Decision Trees (FDA MDR, Canadian, European)
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
Medical Device Quality Management System | BASE PLUS SYSTEM
The Medical Device Quality Management System | BASE PLUS is configured for companies engaged in the design and manufacture of medical devices who need only the minimum required content to obtain ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 38 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING
The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 60 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING PLUS
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 72 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download