US FDA 21 CFR 820.30 Design Control-Operon strategist

1. Importance and Regulatory aspects of Design Control Call / Whatsapp - 9325283428 www.operonstrategist.com

2. 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. 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. Call / Whatsapp - 9325283428 www.operonstrategist.com

3. 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. Call / Whatsapp - 9325283428 www.operonstrategist.com

4. 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 the similar devices is also an 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 creates the poor design outputs. Call / Whatsapp - 9325283428 www.operonstrategist.com

5. The product characteristics required to achieve the design input expectations are called “Design outputs”. The design outputs are normally in form of the raw material specifications, finished good specifications, drawings, in-process controls, types of machinery 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. During all the stages of the development, the “Design reviews” of the activities shall be performed by the team members and the peer reviewers to check if the project is being moved to achieve the user needs. The comment from the reviews will determine the changes in the plan or the design and shall be circulated to all the team members. Call / Whatsapp - 9325283428 www.operonstrategist.com

6. The adequacy of the design output against each of the design input shall be demonstrated. It can be achieved through the set of experimentation and the activity is called “Design Verification”. The design verification activity shall be done by creating the test cases for each of the design output and corresponding input. The typical example of the verification studies may be technical, physical, chemical characterization or other engineering analysis, bench testing etc. The test protocols are approved before execution and are executed and data collected. Call / Whatsapp - 9325283428 www.operonstrategist.com

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