We understand what is required for a medical device assembly machine. 75% of our business comes from the medical device industry.
We know what you need because we go through the process every day. We understand what you need to validate and run you system in compliance with the FDA requirements.
Validation and GAMP
During the time that good automated manufacturing practice (GAMP) was being developed, we were already working with our customers to validate their equipment. We will work with you throughout all of your validation documentation, including:
– Traceability Matrices
– Software Validation
– Hardware Validation
Vision Verification and Calibration
As a medical device company, you’re going to need pre- and post-batch verification. We make this process as simple as possible. All vision inspections have verification targets and programming to verify inspections are performing as validated
I/O Checks and Verification
For a validated machine it is critical that everything works every cycle of the machine. Our programmers make sure that each critical sensor transitions. If the program does not see each sensor change state, the system will generate an alarm and notify the operator that the sensor is malfunctioning or is not properly adjusted.
Innovative is familiar with the Traceability Matrix. Not all customers require them, but if you do need one, we can provide this document.
Innovative will provide a spreadsheet format cross referencing each of the following documents:
– The customer’s User Requirements Specification (URS)
– The system Functional Specification
– The FAT documentation
We can create batch start-up interfaces that walk operators through all of the steps necessary to begin a production run.
Batch start-up interfaces make sure your team goes through all of the necessary steps to ensure a valid run. They can help operators to:
– Scan incoming product
– Perform sensor verifications
– Print product labels for verification
– Verify dispense volumes
– Verify laser markings
– Verify scale accuracies
– Verify all qualifying measurement instruments
We insure that the equipment we provide is compatible with various classes of clean rooms.
-Collecting exhaust from valves and piping it to a manifold (to be brought outside of the room).
-Collecting all laser fumes and running them through HEPA filters.
-Selecting components for clean room compatibility.
Choosing the Correct Materials
The choice of material is important for medical device nests and contact tooling. That is why we make sure that all materials that contact your product are FDA approved. We will provide certifications where Bovine-Free materials are a concern
Navigating Validation Requirements
We know about your validation requirements. We design medical device assembly machines with validation at the forefront. When we work together, all modifications to your equipment during debug and test are documented and revision-controlled. The documentation you receive reflects the machine you validate.