Transfer of Engineering Operations to mdevdev Milestones
Customer will transfer design history files, device master records and device history records into mdevdev quality system during the contracting agreement.
This process includes a signing of standard non-disclosure and confidentiality documents.
A team meeting, including the engineering and business development teams, will be held to forecast a sales demand schedule
A team meeting, including the regulatory and quality control teams, will be held for compliance planning
A team meeting with mdevdev engineering will plan for the supply chain management
Supply sources will be determined and transferred into mdevdev's quality system
mdevdev will assume regulatory accountability for the customer’s technology
mdevdev will create an onsite receiving, inspection, storage and distribution system for the product
The customer tours the mdevdev facility, audits the established operations created for the product distribution and approves the quality system
management
At predetermined intervals, mdevdev will internally audit customer-specific quality system and provides results to the customer
At predetermined intervals, the customer will receive performance reports regarding quality control and regulatory compliance
Quality Management and Product Launch Milestones
Customer will transfer design history files, device master records and device history records into mdevdev quality system
A team meeting, including the regulatory, engineering and business development teams, will be held to plan for regulatory notification and
approval
mdevdev engineers will finalize the device master record
A team meeting, with the engineering and business development teams, will be held to forecast a sales demand schedule
A team meeting, with the regulatory and quality control teams, will be held for compliance planning
A team meeting with the engineering team will plan for the supply chain management
Supply sources will be determined and transferred into mdevdev's quality system
mdevdev will create an onsite receiving, inspection, storage and distribution system for your company’s product
The customer tours the mdevdev facility, audits the established operations created for the product distribution and approves the quality system
management
At predetermined intervals, mdevdev internally audits customer-specific quality system and provides results to customer
At predetermined intervals, the customer will receive performance reports regarding quality control and regulatory compliance