Implantable Medical Device Manufacturer Going Out of Business - Complaints

[lwidman]

A medical device manufacturer who manufactured an implantable device is going out of business. What are the regulatory requirements with regard to potential future complaints? Document retention?

 

[Ajit Basrur]

Re: Medical device manufacturer going out of business - Complaints

Is the company an OEM or a contract manufacturer?

 

[lwidman]

Re: Medical device manufacturer going out of business - Complaints

The company is an OEM and uses a contract manufacturer.