Remedial Action - Recall Procedure | ISO 13485 | FDA QSR Compliant
The Remedial Action / Recall Procedure establishes the process for implementing remedial action for violate medical device product. The Remedial Action / Recall procedure applies to all medical device products marketed domestically and internationally.
- 21 CFR Part 7 Compliant
- FDA QSR Compliant
- ISO 13485:2016 Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Remedial Action | Recall ProcedureThe Remedial Action / Recall Procedure establishes the procedure for implementing remedial action for violate product. The Remedial Action / Recall Procedure applies to all products marketed in the United States and internationally.
Remedial Action / Recall Procedure - OverviewThe Remedial Action / Recall Procedure includes detailed instruction on conducting remedial action investigations, development of a remedial action plan, product corrections, communication method, implementation and effectiveness checks, status reports, and close out and termination of remedial action / recall.
The Remedial Action / Recall Procedure includes a remedial action plan template, sample consignee letter, consignee reply form, sample recall effectiveness check form and a tracking recall spreadsheet. Remedial Action / Recall Procedure - ComplianceThe Remedial Action / Recall Procedure is FDA QSR, MDR EU 2017/745 and ISO 13485:2016 compliant.
For more information about our Remedial Action / Recall Procedure contact us at [email protected]
RELATED LINKS |
Remedial Action / Recall Procedure
|
Customer's also viewed
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
Failure Investigation Procedure
The Failure Investigation Procedure defines the process of conducting a failure investigation when a medical device fails to me product performance specifications. Failure investigations are intended to determine root cause for failure and to provide adequate solutions to correct and prevent problems from reoccurring.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Includes Related Forms
- 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