Design Controls establish your medical product's Device Master Record (DMR) or Master Manufacturing Record (MMR). The DMR or MMR captures all of the product specifications and manufacturing procedures needed to consistently produce your new medical product.
Device Master Record (DMR):
The Device Master Record (DMR) is a comprehensive compilation of all the information necessary to manufacture a medical device. It serves as a blueprint for the production process, ensuring consistency, quality, and regulatory compliance. The DMR typically includes:
- Design Specifications: Detailed descriptions and drawings of the device, including dimensions, materials, and components.
- Production Process Specifications: Step-by-step instructions for manufacturing the device, including machinery, tools, and equipment used.
- Quality Assurance Procedures: Protocols for testing and inspection to ensure the device meets quality and safety standards.
- Packaging and Labeling Specifications: Requirements for packaging and labeling the device, ensuring proper identification and compliance with regulatory standards.
- Maintenance and Servicing Procedures: Guidelines for maintaining and servicing the device to ensure continued functionality and safety.
The DMR is a critical document for ensuring that every unit of the medical device is manufactured consistently and meets all regulatory and quality requirements.
Master Manufacturing Record (MMR):
The Master Manufacturing Record (MMR) is a detailed document that outlines the entire manufacturing process for a medical product. It ensures that each batch or lot of the product is produced according to the same specifications and quality standards. The MMR typically includes:
- Batch Formula: The specific ingredients and quantities required for each batch.
- Manufacturing Instructions: Detailed procedures for manufacturing the product, including equipment and processing steps.
- Quality Control Procedures: Tests and inspections conducted during and after manufacturing to ensure the product meets quality standards.
- Packaging Instructions: Guidelines for packaging the product to ensure it is protected and properly labeled.
- Record Keeping: Documentation of each batch or lot produced, including dates, quantities, and any deviations from the standard process.
The MMR is essential for maintaining consistent product quality and ensuring compliance with regulatory requirements.
You must operate this manufacturing environment in a state of control that demonstrates that you are consistently producing your product, and that you comply with FDA Good Manufacturing Practices (GMPs) and ISO standards. To assure this state of control, you need to conduct internal audits. You will also be required to demonstrate this to 3rd parties like the FDA and Notified Bodies (certifications).
Services offered:
- Medical device consulting
- Design verification and FDA 510k submission
- Design validation and premarket approvals, humanitarian use device and exemption applications (PMA, HUD/HDE)
- FDA registration and listing
- Small Business Decision
- Device Master Record consulting
- Clinical study design and management
- Clinical trial master file
- Clinical regulatory consulting