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Design Control: Importance And
Regulatory Aspects
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Anil Chaudhari
CEO
Operon Strategist |
The Design and Development of the product play vital
role in total life cycle of product and to ensure the effective and safe
product in market. The well-planned and documented approach is expected
while conducting the design and development (D and D) activity.
The Design and Development of the product play vital role
in total life cycle of product and to ensure the effective and safe product
in market. The adequate design documentation helps to improvise the product
performance while product remains in market. As per FDA data, significant
portion at about 44 % percent of the recalls of medical devices are due to
lack of the adequate Design Controls. The minimum expectations are clearly
laid down in 21 CFR part 820.30 and Clause 7.3, ISO 13485:2016.
As per expectations design and development activity has to be
performed and evidenced through DHF at the contract manufacturing site,
Legal manufacturers site, design and development firm as per the business
module and it shall be continually maintained and upgraded.
The design control initiates at the stage, where the
manufacturer decides to make a product and start finding the marketed
products already available in the market, we can call them as a “Predicated
devices”. The manufacturer is expected to create the “ Design Team” which
shall have the Product designers, Regulatory expert, QA experts,
representative of the user, manufacturing expert, marketing representative,
the internal reviewer and the peer reviewer. The representation and
hierarchies of the activities are given in Figure 1: |
The well-planned and documented approach is expected while
conducting the design and development (D and D) activity. The adequate “design
plans” are shall be available during all stages of the Design and development,
defining the roles and responsibility in timed manner for of all team members.
The design plans are continually updated as the activity progresses.
The study of the marketed products and data collected about the characteristics
of the products can be used as design inputs. The design inputs are also
collected from the Initial risk analysis as per ISO 14971, “Medical devices —
Application of risk management to medical devices”. By Performing the usability
Engineering studies as per standards, like ISO 62366 “Application of usability
Engineering to medical devices”. The recalls happened before on the similar
devices is also a important study to get away from the similar design flaws. All
the data collected from the available studies and resources are used as “Design
Inputs”. The manufacturer shall always try to establish as much as possible the
available data to create the design inputs. The design inputs shall not be
ambiguous and shall be clearly defined, which helps to create the adequate
design outputs. It follows the philosophy of “Garbage in Garbage out” poor
design inputs create the poor design outputs.
The product characteristics required to achieve the design input
expectations are called as “Design outputs”. The design outputs are normally in
form the raw material specifications, finished good specifications, drawings,
in-process controls, machineries and equipment required, process flow charts,
vendor details etc. The “traceability matrix” shall be created to demonstrate
the linkage between design input and the design outputs. |
