Page 64 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 43

Note that this covers foreign entities who perform these functions. The significant exception is
that manufacturers of components or parts are not covered. The easy case is when a company
manufactures its own product and puts its name on it. In this way, the manufacturer is clearly
identified. Outsourcing has changed this picture. Now there may be many different manufacturers
involved in one product.
A company who designs or partially designs a product and then has it built by another com-
pany is known as a specification manufacturer. It is primarily responsible for quality and for con-
formance with QSR. Whatever company actually assembles the finished product is also a
manufacturer. The companies that provide components are not manufacturers. However, a con-
tractor who packs or sterilizes the product would be a manufacturer. Each of these “manufacturers”
is responsible for the performance of the portions of the QSR that relate to their task. At the top
of the pyramid, the specification manufacturer remains responsible for everything.

(2) What does the QSR require?
The QSR covers all phases of a product from design to traceability to customers. The significant
areas of coverage are
• Design
• Manufacturing
• Packaging
• Storage
• Installation
• Servicing

In order to comply with the QSR you must have a system. Most sections of the QSR require that
you “establish” systems. This means that there must be written procedures, along with documentary
evidence that you are working under the procedures. The old FDA canard is: “If it’s not written
down, it didn’t happen.”
The sections of the QSR are as follows:
Subpart A: General Provisions. This introductory subpart contains some important provisions.
The scope of the QSR is defined here. This is where component manufacturers are exempted from
QSR compliance. ∗
This subpart explains the flexible nature of QSR in that it only requires compliance for those
activities you actually perform. For example, if you do not distribute, you do not have to show com-
pliance to that part of the QSR. It also explains the term where appropriate. This means that you can
excuse yourself from an irrelevant portion of the QSR if you properly document it.
Subpart A also include the definitions for the QSR. This is a pivotal set of information. The real
†
context of the regulation often lies in the definition. For example, the definition of manufacturer
really determines who is covered by QSR. Most of the important design control records are defined
here. The important definition of validation is found here. When interpreting a section of the QSR,
remember to look back into these definitions to see if relevant meaning is found here.
Subpart A also includes the important overall requirement to establish and maintain a quality system. ‡

§
Subpart B: Quality System Requirements. Management responsibility is a key concept in the
QSR. FDA views this as the heart of the system, upon which all other modules depend. The main
obligations of management are

∗
Id. § 820.1(a).
†
Id. § 820.3.
‡
Id. § 820.5(c).
§
Id. § 820.20.