Medical Device Single Audit Program Checklist
$200.00
Description
This MDSAP audit Program checklist covers Management responsibilities, device life cycle, risk management, document control, purchasing and supplier controls, production and process controls, packaging and labeling, adverse event reporting and vigilance, internal audits, and management of nonconformities.
What is an MDSAP Audit?
The MDSAP program aims to streamline the regulatory processes for medical devices by harmonizing audit requirements and reducing redundant inspections. Instead of multiple audits by each participating country’s regulatory authority, manufacturers can undergo a single audit performed by an authorized MDSAP auditing organization. The audit assesses the manufacturer’s quality management system (QMS) and its compliance with applicable regulatory standards, such as ISO 13485 (Quality Management Systems for Medical Devices).
Why do I need an MDSAP Audit Checklist?
The MDSAP Audit Checklist is important because it allows Streamlined Regulatory Compliance, Market Access for various countries, Reduced redundancy with various audits, and enhanced patient safety. Overall, it is important because it simplifies the regulatory landscape for medical device manufacturers, facilitates market access, promotes international harmonization, reduces redundancy, and enhances patient safety.
What’s included in the MDSAP Audit Checklist?
Rook Template MDSAP Audit Checklist
This checklist will assess the quality system requirements for compliance with MDSAP. After using this document you will be able to open corrective actions or preventative actions. This internal auditing organization conducts a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
Rook Template MDSAP Brazil Audit Checklist
This checklist will assess the quality system requirements for compliance with MDSAP specifically for brazil. After using this document you will be able to open corrective actions or preventative actions. This internal auditing organization conducts a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
Rook Template MDSAP Canada Audit Checklist
This checklist will assess the quality system requirements for compliance with MDSAP specifically for Canada. After using this document you will be able to open corrective actions or preventative actions. This internal auditing organization conducts a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
Let RookQS help with your MDSAP Audit
Rook can assist in conducting this internal audit that allows your company to be compliant with the MDSAP certification. We can also answer any questions and guide you through this process of obtaining this certification. Look to Rook!
