Design controls need to start with user needs If you're in the field of medical device product development, then you do understand the importance and requirement to determine and document Medical Device Design Controls .need not describe the importance but this is mandatory regulatory requirement. Business exists because of customer and here customer is USER either doctor or personnel in this field or sometime person himself/herself. User gives need for product and that becomes starting point for design plan. And once planned and processing further there may be some requirement to suit plant, machinery which makes that product, but ultimate control considers user-needs, and you cannot downgrade the need without the consent of user. You can always make better to fulfil user needs. Remember following steps involved in design, 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Establish a thorough and complete Design Plan. Design Inputs need to be requirements verified using a verification protocol. (User Needs) Design Outputs are drawings and specifications. (User needs satisfied) Design Reviews should have defined deliverables. Design Verification protocols should be standardized, instead of being project-specific so that you do not miss any elements needed. Design Validation should be more than bench testing. It accounts for entire process of making and checking. Design Transfer is not a single event in time. Depends on complexity of product. Do not keep the DHF open after commercial release. This is final so release must be only after DHF is reviewed and closed for all aspects. Your DMR Index should perform a dual function of also meeting technical documentation requirements for other countries. Audit your Design Control process. Address all issues found during audit.
Iziel follows following steps described in following diagram. You can take support of Iziel and its expert as this aspect is very important step of any medical device.
User Needs get the design Control process going. And User Needs are necessary to completely validate the medical device design before getting to production and therefore the market. I consider this even though your project is mid-stream within the product development process. there's value in having solid User Needs defined and understood by the team. because the waterfall suggests, User Needs feeds directly into Design Inputs. you would like User Needs to define Design Inputs. As you approach the launch of your product, you furthermore required to complete Design Validation, which demonstrates your product meets User Needs.