If a manufacturer of a Class II medical device decides to stop operation, or goes bankrupt, what are its obligations concerning maintaining the devices in the market?
Will the company still have to maintain a Quality System?
How does the lifetime of a product come into play?
Will appreciate any guidance on this matter.
You posit two entirely different situations. Actually, three, if you consider there are two broad types of bankruptcy - (1) REORGANIZATION AND (2) LIQUIDATION.
If an organization decides to stop making ANY product (for any reason which may be a whim or a financial reorganization), but continues to do business, then it faces statutory and contractual hurdles in whether it provides for a successor, safety stock, recall, fire sale, whatever. A lot depends on whether the product is a proprietary one or a commodity.
A company that ceases doing business (liquidation) has no legal obligation in regard to disposition of inventory (finished goods or work in process), designs, process equipment, or personnel. Consider the analogy (a poor one) of some man made or natural disaster completely obliterating the organization, its premises, its designs, its intellectual property, its personnel. The dead folks (personnel and executives) of the organization are literally just as dead in a liquidation, so they can no longer be held responsible for anything.
If you have a specific question or fear, it is probably best to take it up with an attorney familiar with you or with the organization and who has access to information about contracts and statutory obligations.
On a more cynical note, unless you are in the top tier of managers of an organization undergoing such change, your primary worry should be
"What happens to me?" not,
"What do we owe the customer?" because the ramifications for the customers will rarely affect you as a regular worker.
Added in edit: If you ARE in the top tier of managers in an organization contemplating this change, consider hiring a qualified consultant to help you sort through all this with the least amount of personal grief to yourself and family.