Page 65 - Biomedical Engineering and Design Handbook Volume 2, Applications

44 MEDICAL DEVICE DESIGN

(1) Establish a quality policy and ensure it is understood.
(2) Establish an organizational structure to assure compliance.
(3) Provide adequate resources.
(4) Appoint a management representative with executive responsibility to ensure that the quality
system is established and to report on its performance.
(5) Conduct management reviews, including review of the suitability and effectiveness of the quality
system.
∗
Subpart B also defines the concept of quality audits which are an ongoing part of an operating
quality system. FDA wished to encourage self-correction through the audit system, so it decided not
to inspect the records of such audits. This allows a company to aggressively search into its systems
without fear that an investigator will use the findings against them. Investigators will look for records
proving that the audit system is in place and is working.
This subpart also defines the need for sufficient personnel with the background and training to
operate under the quality system. †

Subpart C: Design Controls. The inclusion of design controls, a major concept harmonized from
ISO standards, into device GMPs was one of the most important steps in creating the QSR. This was
a major departure from the previous concept of device GMPs, which focused on manufacturing. This
extended the control of QSR over virtually the entire device life cycle.
Design controls cover all Class III and Class II devices. Class I devices are generally exempt from
‡
design controls, except for a handful of specifically listed devices.
Design controls require that manufacturers have a documented design control system:
Each manufacturer shall establish and maintain plans that describe or reference the design and develop-
ment activities and define responsibility for implementation. The plans shall identify and describe the
interfaces with different groups or activities that provide, or result in, input to the design and development
process.
Id. § 820.30(b).

Many manufacturers are adopting software control systems to ensure that all steps in the process
are completed and documented. This overall planning and control is an essential part of an ISO-style,
top-down quality system.
This system must include design review procedures. The QSR states

Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of
the design results are planned and conducted at appropriate stages of the device’s design development.
The procedures shall ensure that participants at each design review include representatives of all functions
concerned with the design stage being reviewed and an individual(s) who does not have direct responsi-
bility for the design stage being reviewed, as well as any specialists needed.
Id. § 820.30(e).

These reviews must be documented in a Design History File (DHF).
The major steps in the design control process are
(1) Design input
(2) Design output
(3) Design verification

∗ Id. § 820.22.
† Id. § 820.25.
‡ Id. § 820.30(a).