Q
Hello...
Our company is a contract manufacturer that is ISO 13485 certified. We are exempt from all design within the standard as we only have a value add role. Meaning that we take our clients products (all types of products including medical, CD's, DVD's) and package the products according to their specifications. We are not a device manufacturer in any way. We only provide printed packaging materials, corrugated master cartons, assembly and fulfillment services.
Would appreciate any input that anyone has for the following questions we have:
1. Since we are ISO 13485 certified, are there any restrictions or additional requirements besides the ISO certification for packaging and shipping Class II Medical Devices?
2. The Class II device that we are going to package and ship for our client is a prescription. Prescriptions would be sent to us to be fulfilled. Is there any restrictions or additional requirements besides the ISO certification?
3. We are also registered with the FDA as a contract manufacturer, are there any restrictions or additional requirements for FDA?
4. We are also registered with the State of CA as a contract manufacturer, are there any restrictions or additional requirements for State of CA?
5. Last question is in regards to HIPAA (Health Insurance Portability and Accountability Act) for Privacy. Are there any requirements or certifications required for HIPAA?


Our company is a contract manufacturer that is ISO 13485 certified. We are exempt from all design within the standard as we only have a value add role. Meaning that we take our clients products (all types of products including medical, CD's, DVD's) and package the products according to their specifications. We are not a device manufacturer in any way. We only provide printed packaging materials, corrugated master cartons, assembly and fulfillment services.
Would appreciate any input that anyone has for the following questions we have:
1. Since we are ISO 13485 certified, are there any restrictions or additional requirements besides the ISO certification for packaging and shipping Class II Medical Devices?
2. The Class II device that we are going to package and ship for our client is a prescription. Prescriptions would be sent to us to be fulfilled. Is there any restrictions or additional requirements besides the ISO certification?
3. We are also registered with the FDA as a contract manufacturer, are there any restrictions or additional requirements for FDA?
4. We are also registered with the State of CA as a contract manufacturer, are there any restrictions or additional requirements for State of CA?
5. Last question is in regards to HIPAA (Health Insurance Portability and Accountability Act) for Privacy. Are there any requirements or certifications required for HIPAA?
