BDL.consulting back up our mechanical engineering services with the required Design Controls and Documentation for the MDR / DHF to ensure that your product will be CE and FDA compliant. When creating designs for new products we automatically create the Design inputs and Outputs for the Devices and manage them with our Design Controls that are filed on our MDR /DHF data base. All documents can be supplied to the customer as part of the Project.
- Design Controls
- Risk Management
- Document Controls and Record Management
- Supplier Management