Joe Selva Rohan Thakkar Jean Valderrama “Documentation” is what’s written on paper Provides written details, events, and information about a particular process. Using documentary evidence to confirm that a fact or statement is true. Can include, but not limited to: Operator manuals Instruction sheets Online help systems Maintenance manuals Communication should be maintained throughout the documentation process Clear writing, complete information, and good organization are, of course, key to the success of any design document. If it isn’t documented, it didn’t happen! Creates paper trail tracing design documentation Maintains proof of design process Meets governing body requirements Everything throughout the process! Meetings: date, length, attendance, purpose, and outcomes. Ideas: thoughts and sketches Prints: models, computer generated drawings (CAD, Solidworks, etc.), and tolerance stack-ups Phone calls: date, time, and purpose. Reference to other manuals: manufacturing processes and material manuals. Emails sent back and forth throughout Testing: standards, calibration of equipment, where the test happens, materials used, etc. Notebooks Preliminary sketches Meeting discussions Concept development and ideas Email Messages Discussion on design development, with all parties involved (i.e. professors, physicians, engineers, team members, etc.) File Folders Binders Computerized Copies Microsoft Office Files (Word, Excel, etc.) Forms specific per company Forms provided by the FDA or other organizations to regulate products Business Proposal Product Specifications Design Specification Software Quality Assurance Plan (SQAP), where applicable Software Requirements Specifications (SRS), where applicable Software Design Description (SDD), where applicable Design History File (DHF) Design Input Design Output Design Review Verification and Validation Device Master Record (DMR) Device History Record (DHR) Design Transfer Design Change Technical Documentation File (TDF) FDA Required Documents An Executive Summary introducing what will be provided to the customer and how they will benefit from it. Product Overview, Objectives, Major Milestones, Schedule Market need and market potential Product proposal Strategic fit Risk analysis Economic analysis Supporting documentation Statement of what a not-yet-designed product is intended to do. To ensure that the subsequent design and development of a product meets the needs of the user. Type of product Market it addresses Function of the product Accuracy requirements Safety issues Reliability goal Provides explicit information on the requirements for a product and how the product is put together. Manufacturing strategy Safety Cost budgets Size and packaging Standards requirements Environmental constraints The purpose of (SQAP) is to define the techniques, procedures, and methodologies that will use to assure timely delivery of the software that meets specified requirements of the project. Develops and documents the software development, evaluation and acceptance standards. Assures that the results of software quality reviews and audits will be given to appropriate management department. Assures that test results adhere to acceptance standards. SRS is a complete description of the system to be developed. It describes all the interactions the users will have with the software. In addition, the SRS also contains nonfunctional requirements which impose constraints on the design or implementation. Such as: Quality Standards An SDD is a representation of a software design that is to be used for recording design information addressing various design concerns and communicating that information to the design’s stakeholders This includes traditional software construction activities, when design leads to code, and “reverse engineering” situations where a design description is to be recovered from an existing implementation. Compiles records describing the design history of a finished device Complies with FDA requirements for marketing medical device FDA Requirement: “Each manufacturer shall establish and maintain a DHF for each type of device. The Device shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approval design plan and the requirements of this part.” Code of Federal Regulations, Title 21 – Food and Drugs, Chapter I – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices. Specific to each company Design review meeting information Design plans Inputs and Outputs Sketches Drawings Photos Emails Notebooks Biocompatibility Reviews Verification and validations Test procedures Functional Requirements Performance Requirements Strength and durability Product longevity Sterilization Packaging/Labeling requirements All functions the final product must perform Is special packaging needed for this device? Human factors Immune response to foreign body Results of design and engineering. How are they documented? Specifications of the final device- Manufacturing process, measurement or test methods Models, drawings, engineering analysis and other documents Output must be traceable to input requirement. Formal review of device Conducted by representatives involved in design effort and any other interested parties (e.g. sales, marketing, manufacturing engineering). Documented in DHF Date, participants, design version reviewed, results of review Verifies the output conforms to design input. Validated using initial/low production process. Making sure the device works using normal production process rather than using prototype processes Tests, inspections, analyses. Can the workers of the manufacturing company produce multiple functional prototypes? Documented in DHF Verification date, participants, design version reviewed, and review results. Routine documentation required to manufacture devices that meet the company requirements. Contents Device Specification • Drawings, composition, formulation, component specifications, and software applications Product Process Specifications Equipment specifications, production methods and procedures, and production environment specifications Quality Assurance Procedures and Specifications Quality Assurance- determining whether or not a product/ service meets the customers expectations. • Design, development, production and service of product are considered Packing and Labeling Specifications Installation, Maintenance, and Service Procedures and Methods Shows all operations, processes, etc. described in the DMR have been accomplished for the finished device and also includes: Date(s) of manufacturing Quantity Manufactured Quantity released for distribution Any device identification and control number(s) Primary identification label Labeling used for each production unit Acceptance records which demonstrate the device is manufactured in accordance with DMR. Device History File- how you developed the recipe for making your device Device Master Record- the recipe for making the device Specifications, work instructions, inspection procedures. Device History Record-The “batch” or lot of devices was made according to the recipe. Transfer of product from design engineering to manufacturing. Includes detailed production specifications Detailed product drawings, workmanship standards, manufacturing instructions, inspection criteria, heat treat conditions, etc. Some components might be purchased elsewhere, integrates them in the process. Increases efficiency and quality of production Communicates and documents changes throughout design process Shows date and time when revisions occurr Traces development of new product Approved and signed off on by appropriate departments during development Contains all relevant design data which the product can be demonstrated to satisfy the essential safety requirements which are formulated in the Medical Device Directives. Medical Device Directives- Regulations set forth to legally place a medical device on the European market General description of the product, including any planned variants Design drawings, methods of manufacturing envisaged and diagrams of components, sub-assemblies, circuits, etc. Descriptions and explanations necessary to understand the above mentioned drawings and diagrams and the operations of the product Results of the risk analysis and a list of applicable standards applied in full or in part, and descriptions of the solutions adopted. In the case of products placed on the market in a sterile condition, a description of the methods used Test reports and, where appropriate, clinical data Labels and instructions for use Document that tries to foresee possible risks and provides response plans to avoid the impact of reoccurring errors. Design Failure Mode Effects Analysis (DFMEA) Process Failure Mode Effects Analysis (PFMEA) Medical Device Definition Device Classification 510k Design and development plans Design reviews Design verification Validation testing and results Product specification Premarket Approval (PMA) Good Manufacturing Compliance (GMP) Assume everything you hear, say, think, write, read, and create is important no matter how insignificant, trivial, irrelevant, or inconsequential you might think it may be. Record, date, sign, and save everything throughout the devices design. FDA will come in to audit all information for approval.