Medical Design Briefs - December 2021 - 20

Biomedical QC Testing
Method
Calculations used
Software version
Method set up
Inadequate specifications
Testing procedure
Algorithm
Handling
Properties
Geometry
Interface with system
Preparation
Material
The consequence and magnitude of a
test error depends on what the error is.
Testing at body temperature vs. room
temperature can drastically affect
results. A ±1 percent measurement error
of a specimen's dimensions will result in
a ±2 percent error in the stress result. An
incorrect machine calibration means
that all test measurements and results
are invalid - resulting in product being
recalled or scrapped.
To resolve these inconsistences, the
first course of action is to perform an
audit of the lab, equipment, and operating
procedures to see which of these variables
could be causing the inconsistency
in test results. Modern testing equipment
provides many opportunities to reduce
the likelihood of erroneous results, ranging
from system setup optimization to
requiring admin-level permissions to edit
test methods and calculations. The quality
of audit results can also be evaluated
using a Gage Repeatability and Reli -
ability (GR&R) study, which is used to
qualify and/or validate equipment and
" quantify " total system error.
Regulatory Compliance
Regulatory compliance is possibly the
biggest challenge facing any manufacturer
in the biomedical device industry
and testing equipment and software validation
are critical for achieving this
compliance (see Figure 3). Although
there are several different
regulatory
standards that testing laboratories often
need to meet, the two most common are
21 CFR Part 11 (Electronic Records and
20
Cov
Measuremennt
Calibration
Drift & noise
Dynamic effects
Data acquisition
Operator
Procedural errors
Technique
Specimen measurement
Thermal effects
Resolution
Mass & stiffness
Damage & wear
Alignment
Machine control
Backlash
Interface with accessories
Machine
Installation
Environment
Fig. 3 - Fishbone diagram showing major categories for error sources that can affect the accuracy of a testing system.
Electronic Signatures) and 21 CFR part
820 (Quality System Regulation/ Med -
ical Device Good Manufacturing Prac -
tices). Although these standards have
broad-ranging requirements, materials
testing suppliers offer products and services
designed for companies testing in
highly regulated environments.
21 CFR Part 820
All laboratory product development
and manufacturing processes are subject
to 21 CFR Part 820 validation. Materials
testing suppliers typically assist companies
in the required creation of a qualification
plan. This plan typically includes
several phases: performance specifications,
risk analysis (RA), design qualifications
(DQ), installation qualifications
(IQ), operational qualifications (OQ),
and performance qualifications (PQ).
Most materials testing suppliers provide
independent assessments and documentation
for the IQ and OQ, which typically
includes system checks, transducer and
system verifications, functional checks of
test software, and validation of calculations.
Laboratories working collaboratively
with testing suppliers in the development
of robust RA and DQ documentation
as well as fulfillment of the PQ can
save valuable time as well as internal costs
associated with the validation process.
ISO 13485
ISO 13485 supports medical device
manufacturers in designing quality management
systems that establish and maintain
the effectiveness of their processes
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ToC
for consistent design, development, production,
installation, and delivery of medical
devices. The differences between 21
CFR Part 820 and ISO 13485 are subtle,
but recent revisions (2016 for ISO and
2018 for Part 820) now have them wellaligned.
Conformance to ISO 13485 is an
internal decision while 21 CFR Part 820 is
an FDA-mandated system of product
design quality. Due to their similarities,
organizations can use the implementation
of ISO 13485 to establish compliance
to 21 CFR Part 820. Some requirements
of 820 might not be fully covered by
13485, but a simple gap analysis and proposed
actions to fill those gaps can ensure
compliance to 820. Similar to 21 CFR
Part 11, noncompliance is not an option.
21 CFR Part 11 Compliance
The 21 CFR Part 11 standard initially
created a great deal of tension within
the medical device and pharmaceutical
industries, with the most common concern
being the potential cost of achieving
compliance. There was also considerable
confusion regarding implementation
processes and procedures. Several
guidance documents were written by the
FDA to clarify the situation.
Along with other companies, materials
testing suppliers were challenged to
supply testing systems and software that
could comply with the broad scope of
the regulation. One common fallacy is
the notion that materials testing systems
manufacturers can provide " 21 CFR Part
11 compliant software. " In reality, it is up
to the user to establish processes and
Medical Design Briefs, December 2021
Temp & humidity
Power
Vibration
Air quality
System set up
Specimen handling
Total System
Error

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Medical Design Briefs - December 2021

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