J
Hello all! Thanks to everyone who posts here - it is an incredibly useful resource.
I work at a start-up, pre-revenue medical device company (<5 employees).We are the responsible design/manufacturers but all production, sterilization, storage and shipping is outsourced to another (ISO 13485 registered) company. We have set up the framework for ISO 13485 and am planning for implementation in the next few months for our first audit possibly in the summer.
I am a little stuck in a "chicken and the egg" situation. We cant sell our product until we are ISO 13485 certified, but for our first audit we will have nothing to show for purchase orders, CAPAs, complaints, etc.
I am wondering if anyone could shed light on what an audit looks like when you are a pre-revenue company? We have all the procedures in place but for some areas of the business it will be next to impossible to actually show compliance to them.
Thoughts?! Thank you in advance!!
I work at a start-up, pre-revenue medical device company (<5 employees).We are the responsible design/manufacturers but all production, sterilization, storage and shipping is outsourced to another (ISO 13485 registered) company. We have set up the framework for ISO 13485 and am planning for implementation in the next few months for our first audit possibly in the summer.
I am a little stuck in a "chicken and the egg" situation. We cant sell our product until we are ISO 13485 certified, but for our first audit we will have nothing to show for purchase orders, CAPAs, complaints, etc.
I am wondering if anyone could shed light on what an audit looks like when you are a pre-revenue company? We have all the procedures in place but for some areas of the business it will be next to impossible to actually show compliance to them.
Thoughts?! Thank you in advance!!