ENGINEERING



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