Importance and Regulatory aspects of Design Control

The Design and Development of the product play a vital role in the total life cycle of a product and to ensure the effective and safe product in the market. The adequate design documentation helps to improvise the product performance while the product remains in the market. As per FDA data, the significant portion at about 44 % of the recalls of medical devices is due to the lack of adequate Design Controls.

US FDA 21 CFR 820.30 Design Control : 

The minimum expectations are clearly laid down in 21 CFR part 820.30 design control and Clause 7.3, ISO 13485:2016.  As per expectations design and development activity have 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 “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 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 the timed manner 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”. Performing the usability Engineering studies as per standards, like ISO 62366 “ Application of Usability Engineering to medical devices”. The recalls happened before on similar devices is also an important study to get away from 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 adequate design outputs. It follows the philosophy of “ Garbage in Garbage out” poor design inputs creates the poor design outputs.

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