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Document Title: Development of Design Input Requirements
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COMPANY PROPRIETARY AND CONFIDENTIAL

.............4 Design Output.....................................2 3...........3 4..............................6 Incomplete................................................................................................................................................................3 4..........................................................................................................................................................................................13 Verification............3 Development of Input Requirements...........2 Customer...................0 Responsibilities.....6 Product..........................................................0 Definitions.....................................................................................................................................................................................................................................................2 3..................4 6..................................................................................................8 Product Development Feasibility Study (PDFS)........4 6...............5 6.......................................3 3.....2 3..............................6 6...................2 3.............................2 3...............................................................................................................................................6 6........................................................... Location] [Document Number] Rev x.....................................................................................................xx DD/MM/YY Table of Contents 1.....................................................................................................................4..............................2 3..............7 [Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 7 .......[Company Name] Development of Design Input Requirements [Company Group..10 Quality.............................11 Product Development Team (PDT)..............9 Change Control......................................................2 3......1 Executive Management Team (EMT)...............................2 Sources of Information for Input Requirements................................3 3.............3 4.................................................................................................1 Executive Management Team (EMT)......................................................2 Product Manager...................................2.....3 4...........................................................................................7 Development of Input Requirements.......................................6 6......................................2 3....4 Product Development Team (PDT)...........6 6.......3 Design Input....................................................................2....7 6............................1 Determination of Input Requirements................................................................................................................................................................3 Interface Requirements.........................................................................................................................................................................4 Categories of Input Requirements.9 Product Manager...7 Product Development.....3 5..... Division..........5 6..............................7 6........................................4 6..................7 6.................................................................................................... or Conflicting Input Requirements............................2 3...........3 Regulatory Affairs/Quality Systems Director.....................................................................0 References and Applicable Documents.....................................................................................................1 Functional Requirements.....................................1 Customer Requirements.....................................0 Purpose....10 Conversion of Input Requirements...7 6..................................................................................................6 6........................................4 System and Product Development Requirements........................................2 Performance Requirements.......................................................................................0 Procedure.....................................................4......................................................................2 2.8 Development of Input Requirements....................................................................................4 6.............................................2 3.....3 4..................4 6............................................................0 Scope..........12 Validation................................................................................................................................................................................................................................................... Ambiguous.................6 6.........2...............3 System and Product Development Requirements..................................................................................................................................5 6..................................................................................3 3............................................................................4..5 Assessment of Input Requirements.......................2 Intended Use Requirements.........................................................................................3 3..................................................................................................................................................4........5 Marketing Requirements Document (MRD)................

3.0 Scope This procedure applies to all product development programs funded and managed by [Company Name]. The total finished design output consists of the product. its packaging and labeling.8 Product Development Feasibility Study (PDFS) The Product Development Feasibility Study examines all applicable facets of a proposed development program to assist in management’s decision to expend time and resources in undertaking development of the product.5 Marketing Requirements Document (MRD) The Marketing Requirements Document specifies design input requirements used as the basis for complete product design. devices. performance. using. materials. and risk management. the word “product” in this procedure is used in the more global sense to refer to components. including manufacturing operations and product development.[Company Name] Development of Design Input Requirements [Company Group. customer satisfaction.2 Customer Anyone purchasing.xx DD/MM/YY 1. quality. 2. The Executive Management Team has the authority to establish or make changes to the quality policy and quality system.0 Definitions 3. directs.3 Design Input The physical and performance requirements of a product used as a basis for product design and development. to the end of the product’s life. and the Device Master Record. etc. It defines what the design is intended to do and details requirements for functionality. software. 3. This study is the first step in the Feasibility Phase of the Product Development Cycle and it evolves into the Product Development Plan during the Planning Phase. operating. or interfacing with a product in any manner. Division. interfacing. Location] [Document Number] Rev x. 3. Approval of the MRD by the Executive Management Team marks the end of the research phases (Concept and Feasibility) and the beginning of a development program. performance.4 Design Output The results of a design effort at each design phase and at the end of the total design effort.9 Product Manager The Product Manager directs the activities of the Product Development Team and the development program in accordance with the process detailed in this procedure and bears overall [Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 2 of 7 . machines. A product development simultaneously integrates all product knowledge and expertise from concept. systems. It has the authority and responsibility to carry out the company’s strategic objectives.0 Purpose This procedure defines the guidelines for establishing and documenting the design input requirements for the development of a product design. processes. 3. 3.1 Executive Management Team (EMT) A management team that plans. through manufacturing and customer satisfaction. 3. The finished design output is the basis for the Device Master Record. 3. cost. or services. as well as system and program requirements and goals. 3.6 Product Unless otherwise specified. structures. 3. and manages company activities.7 Product Development The systematic development process for optimizing a product’s time to market.

4.4 Product Development Team (PDT) The Product Development Team has collective responsibility and authority to plan. It has the authority and responsibility to carry out the development objectives of the Executive Management Team and to advise.xx DD/MM/YY responsibility for management of the development program. the Product Manager is responsible for coordinating and integrating their activities and acting as liaison with the Executive Management Team. It is responsible for development of design input and preparation of the Marketing Requirements Document. The EMT approves the Marketing Requirements Document to initiate a product development program. 3. the Product Manager and the PDT may not exactly follow this procedure.2 Product Manager The Product Manager bears overall responsibility for successful management of the development program and is responsible for leading and facilitating the efforts of the Product Development Team. 3. and manage the activities and deliverables of a development program and to carry out the objectives of the Executive Management Team. As the leader of the Product Development Team. directs. Division.11 Product Development Team (PDT) A cross-functional team that plans. 4.0 Responsibilities This procedure is intended as a guide. and integrate the activities of the Task Teams. The Executive Management Team assigns a Product Manager to a particular product development program. the product. coordinate.[Company Name] Development of Design Input Requirements [Company Group. and all phases of the Product Development Cycle.13 Verification Confirmation by examination and provision of objective evidence that specified requirements has been fulfilled.1 Executive Management Team (EMT) The Executive Management Team has comprehensive responsibility and authority to plan. the Manufacturing Process. 4. direct. the PDT reviews and updates the MRD as required. 1997 [Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 3 of 7 .10 Quality The totality of features and characteristics that bears on the ability of a product to satisfy fitness- for-use. 3. direct.0 References and Applicable Documents “Design Control Guidance for Medical Device Manufacturers”. Location] [Document Number] Rev x. including safety and performance. and manage the business and strategic objectives of product development programs.3 Regulatory Affairs/Quality Systems Director The Director of Regulatory Affairs/Quality Systems is responsible for assuring the quality of the product design process. Depending on the complexity of the product and the extent of the design requirements. but must still apply the essential elements of effective and systematic development of design input requirements.12 Validation Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. 4. FDA Center for Devices and Radiological Health. 5. and manages a development program. March 11. 4. The Product Manager is the leader of the Product Development Team and acts as liaison to the Executive Management Team. As the design evolves. The Executive Management Team is responsible for forming the Product Development Team. 3.

In many cases. The following are examples of the types of information the PDT should acquire: 6.1 Customer Requirements  Diagnostic requirements  Therapeutic requirements  Clinical effectiveness requirements  User expectations  Labeling requirements including operator guidance  Human factors  Safety [Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 4 of 7 . In either case. 6. customer complaints and service records. Other information originates from a variety of sources such as documentation of past projects and studies. etc. the contract review manager is responsible for notifying and coordinating the changes with the PDT. Market research is the primary mechanism for acquiring knowledge of customer needs and requirements. It is one source of design input information. This is a concept document containing a conceptual description of the product. Division.xx DD/MM/YY The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices. The Product Development Team. Kimberly Trautman. etc. the Product Development Team considers many sources and types of information to develop a comprehensive and precise set of design input requirements. elaborates and expands this description into a complete set of design input requirements written to an engineering level of detail. Before and during the Design input Review.0 Procedure 6. the customer and those developing the product both provide input. the use environment.2 Sources of Information for Input Requirements In the Concept and Feasibility Phases of the Product Development Cycle. or any other factor necessary to describe the product throughout its life cycle. The development may be an enhancement or improvement of an existing product. the Product Development Team must also consider other issues pertinent to product design such as regulatory requirements. existing products. the Product Development Team translates customer needs and development needs into a set of requirements that can be verified and validated prior to product implementation. new technologies requiring development and analysis.2. Market research gathers detailed information regarding where and how the product will be used. ASQ Quality Press The Product Development Cycle 6. To obtain a truly comprehensive set of design requirements. the PDT will communicate directly with the manager responsible for contract review to incorporate any changes or additions to the design input requirements resulting from contract review activities. Another source of information is the results of contract reviews. The focus of such information gathering is external to the company. Location] [Document Number] Rev x. Customer requirements mainly govern design input. with additional sources of information. Ultimately. Research and/or Engineering perform experiments and gather information to prepare the Product Development Feasibility Study. competing products.[Company Name] Development of Design Input Requirements [Company Group. If changes to the design input requirements occur after the Design Input Review. a particular product development program does not require a Product Development Feasibility Study. It may be necessary to acquire such information first had such as engineers conducting investigations at selected product use sites to characterize the actual use environment.1 Determination of Input Requirements Development of design input requirements is the starting point for product design and results in a Marketing Requirements Document that initiates the design control process. However. safety concerns. who will use it.

3 Development of Input Requirements The Product Development Team is responsible for translating the information on customer needs and development needs into a set of requirements that can be verified and validated prior to implementation of the product. Give a measurement of tolerance when applicable. concentrate on specifying what the design is intended to do.4.4 Categories of Input Requirements Design input requirements must be comprehensive. Use quantitative terms that can be both verified and validated. [Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 5 of 7 . Design input requirements basically fall into four (4) categories. Division. the Product Manager may need to secure additional representatives from other functional areas.3 System and Product Development Requirements  Cost  Technological viability  Manufacturability  Export requirements  Packaging and shipping  Other business considerations  Delivery and installation  Statutory requirements  Contract review results 6.[Company Name] Development of Design Input Requirements [Company Group. 6. cross-functional activity. 6. Location] [Document Number] Rev x. These classifications are beneficial when later preparing the Product Development Plan.2 Intended Use Requirements  Performance  Functional  Interface  Environmental  Electro-Magnetic Compliance (EMC)  Product/System compatibility  Reliability  Maintainability  Serviceability  Storage and shelf life  Materials  Regulatory requirements  Human factors  Safety  Sterilization  Standards 6. Group the design input into requirement classifications and categories. Though the Product Development Team is cross functional in membership. state the requirement with a to-be-determined (TBD) numerical value or a range of possible values. focusing on its operational capabilities and the processing of inputs and resultant outputs.xx DD/MM/YY  Training 6.2.1 Functional Requirements These specify what the product does. When it is impractical to establish a functional or performance characteristic.2. Write the requirements to an engineering level of detail. Carefully avoid specifying design solutions and instead. This is a broad based. Product complexity and the risk associated with its use dictate the amount of detail.

the reviews should employ a number of criteria.4. One interface to always address is the user and/or customer interface.2 Performance Requirements These specify how much or how well the product must perform.  Precisely state the requirements in unambiguous terms. the PDT will resolve the issue and the Product Manager will make the change and increment the MRD’s revision level.  When reference. including temperature. including the needs of the use and customer. Provide a basis for determining accuracy requirements and suitability for intended use.6 Incomplete. ambiguous. If such a problem is known or discovered prior to the EMT’s approval of the Marketing Requirements Document. if necessary. or conflicting requirements. methods. This includes a quantitative characterization of the use environment. Fully specify the environmental conditions representative of the intended use.  Identify incomplete or “to be determined” (TBD) conditions.4. inspection. 6. the PDT will resolve the issue and the Product Manager will make the change to the proposed MRD.  Express quantitative limits with a measurement of tolerance. Product reliability and safety requirements also fit in this category. electromagnetic compatibil9ity.  State each requirement’s means of measurement and validation. review industry standards for completeness and relevance.  Make the set of design input requirements for a product self-consistent. 6. and support of the product. etc. manufacturing. including the needs of the user and customer. accuracy.5 Assessment of Input Requirements After completion of the design input requirements. Division. appropriate. etc.7 Development of Input Requirements The Product Development Team documents the product design input requirements in a Marketing Requirements Document. which are critical to compatibility with external systems.4 System and Product Development Requirements These specify goals and requirements of the product development and other development issues that are not necessarily just a characteristic of the product itself. The purpose of the review is to ensure the product design requirements are adequate. 6. the Product Manager conducts a design input Review. addressing such issues as speed. After preparation. limits of operation. these are characteristics mandat4ed by external systems and outside the control of the developers.  Properly characterize the product’s use environment. The Product manager may have to conduct multiple reviews before the reviewers satisfactorily resolve every issue. and address the intended use of the product. or Conflicting Input Requirements The PDT and the reviewers must be diligent in finding and resolving incomplete. 6. the Product Manager conducts a Design Input Review to ensure the product design requirements are adequate. Following an audit [Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 6 of 7 . Resolve conflicts between requirements or with referenced industry standards. Specify the cause of the TBD condition as well as what to do to eliminate the cause. Any assessment of design input requirements is essentially a matter of judgment. More specifically.[Company Name] Development of Design Input Requirements [Company Group. and equipment. or testing. Typically. including the conformance assessment procedure. If discovered after approval. 6. appropriate. strength. these are a consequence of development. Ambiguous. response times.4. vibrati9on. Each requirement should be verifiable by an objective method of analysis.3 Interface Requirements These specify characteristics of the product. humidity. Location] [Document Number] Rev x. and address the intended use of the product.xx DD/MM/YY 6. However. shock.

To minimize such an occurrence. When appropriate. the EMT approves the MRD if acceptable.xx DD/MM/YY of the review. 6. the information available is inherently more extensive and detailed as design progresses. These specifications are a design output.10 Conversion of Input Requirements The first step in design development (Development Phase) is converting the product design input requirements of the Marketing Requirements Document into a set of system (upper level) specifications. and other developers conduct formal and informal design reviews throughout the development process. The Product Development Team must carefully manage the change control process to prevent a change that corrects one problem but creates another. or new information that requires changes to the design input requirements. The MRD is a design history document maintained in the Design History File. errors. 6. Location] [Document Number] Rev x. reviews. and other development activities often uncover discrepancies. the PDT ensures that all potential changes are communicated to developers who can determine the full impact of the change.9 Change Control As discussed above. Division. As development proceeds. The Product Manager. Therefore. the output from earlier design stages forms the basis for subsequent stages. the Product Manager and PDT use information from reviews and other sources to update the design input requirements in the MRD. The Product Manager of a specific development program is responsible for controlling and documenting changes to the design input requirements in the MRD.8 Development of Input Requirements The MRD is continuously updated as the design evolves and more information becomes available. [Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 7 of 7 . 6. The EMT approves all updates and changes to the MRD.[Company Name] Development of Design Input Requirements [Company Group. teams. marking the end of the research phases (Concept/Feasibility) and the start of the development program. verification.