Design documentation

1. Design documentation LinaElsamaloty Marcel Ingels

2. Documentation • “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.

3. Documentation (cont’d) • Can include, but not limited to: • Operator manuals • Instruction sheets • Online help systems • Maintenance manuals • Verification and Validation • Communication should be maintained throughout the documentation process • GDP – Good Document Practice If it isn’t documented, it didn’t happen!

4. Importance of documentation • Creates paper trail tracing design documentation • Maintains proof of design process • Meets governing body requirements

5. What needs to be documented • Everything throughout the process! • Technical Reviews: date, length, attendance, purpose, and outcomes. • Drawings: models, computer generated drawings (CAD, Solidworks, etc.), and tolerance stack-ups • Signatories on documents

6. What needs to be documented(cont’d) • Testing: • Standards • Calibration of equipment • Materials used • Method • Scope • Study Design (Statistical Relevance) • Risk Level

7. Forms of Documentation • 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

8. Forms of Documentation (cont’d) • Records • Electronic Document system (JDE, Matrix, etc.) • Hard Copies (in secure document center) • Forms provided by the FDA or other organizations to regulate products

9. Types of Documents • 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

10. Business Proposal 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 • Risk analysis • Economic analysis • Supporting documentation

11. Product Specification 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

12. Design Specification 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

13. Design History File (DHF) • Compiles records describing the design history of a finished device • Complies with FDA requirements for marketing medical device • Specific to each company 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.”

14. Design History File (DHF)(cont’d) • Design review meeting information • Design plans • Inputs and Outputs • Sketches/Drawings • Risk Assessment • Photos • Emails • Notebooks • Performance Testing • Reviews • Verification and validations • Test procedures

15. Design Inputs • Functional Requirements • All functions the final product must perform • Performance Requirements • Strength and durability • Product longevity/Shelf Life • Sterilization • Packaging/Labeling requirements • Is special packaging needed for this device? • Human factors • Immune response to foreign body

16. Design Outputs • Results of design and engineering. • Specifications of the final device- Manufacturing process, measurement or test methods • How are they documented? • Models, drawings, engineering analysis and other documents • Output must be traceable to input requirement.

17. Design Review • 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

18. Design Verification and Validation • Verifies the output conforms to design input. • Tests, inspections, analyses. • Validated using initial/low production process. • Making sure the device works using normal production process rather than using prototype processes • Can the workers of the manufacturing company produce multiple functional prototypes? • Documented in DHF • Verification date, participants, design version reviewed, and review results.

19. Device Master Record (DMR) 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

20. Device History Record (DHR) 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.

21. DMR vs. DHF vs. DHR • 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.

22. Design Transfer • 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

23. Design Change • Communicates and documents changes throughout design process • Shows date and time when revisions occur • Traces development of new product • Approved and signed off on by appropriate departments during development

24. Risk Management • 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)

25. FDA Required Documents • 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)

26. FDA Regulation Guidance

27. Summary • 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.

28. Questions?