Quality is an and should be considered as an integral part of the company. It doesn’t matter what is the size of the company but there should always be a set form of procedure to maintain accountability and flexibility to trace a product backwards to its whole batch in situations to back trace a product lot. This all things can only be achieved only when there is a system in place. Especially in medical device company which always deals human life they need to be accountable.
Even when a company thinks from business point of view allocating sufficient fund would be like an investment into something which ensure following services:
More trust of consumers in a company product.
Better quality product
Prevents company from loosing money from sues.
Gets the products certified from more regulatory boards ( which would be a big plus if its a Multi national Company)
Responsible for accountibility of the manufacturing processes.
Evaluation of vendor material.
Basically a service which prevent loss of money and make sure that anything that goes out in the market with company name on it has been proven to standards is something worth investing money into.