1. Design Documentation Clint Kehres, Brian Krouse, Jenn Shafner

2. Legal Requirements DHF- design history file 1. Not all national regulators are equal. Diligent records at every step.

3. Manufacturer Benefits from Design Documentation Maintain knowledge base of the product design. DHF owner = Company, not individual. Required by Governments – Document everything clearly in case audited.

4. Design Documents Design History File (DHF) Device Master Record (DMR) Design Changes Technical Files FDA Submissions Design and Process Validations/Verifications Risk Management Documentation – Design Failure Mode and Effects Analyses – Process Failure Mode and Effects Analyses Process Routers Drawings Meeting Minutes Inspection Criteria Laboratory Notebooks Design Control Plans Material Specifications Sterility and Cleaning Process Verifications Tolerance Stack-ups

5. Logical Path of Design Development/Control Every step requires design documentation. Each step has its own specific type of documents.

6. Design History File… Exact requirements depend on specific company. -Most are self regulated. FDA States, “Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part”.

7. Methods of Documentation Hard Copy DHF’s and Paperwork Images and Photos Excel and Word Documents Company specific document templates and regulations Digital Document Management System Specific Document Management Departments

8. Design Inputs: The design input requirements shall be documented and shall be reviewed and approved by designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented. Customer requirements must be translated into engineering design inputs. ◦The customer requirements and design inputs are arguably the most important items in a design. ◦Because of their importance, they must be documented very comprehensively and avoid being vague. Requirements are often identified from Marketing team. - Good documentation reduces poor assumptions between the engineering and marketing teams. - Comprehensive identification/documentation of design inputs increases the likelihood of having an efficient development process.

9. Design Outputs: Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Result of detailed designed process addressing design inputs. Outputs include risk management, product specifications, drawings, packaging, etc. Includes a Design Rationale ◦Detailed description of product functions or features ◦Includes general description of various parts of device, functional purpose of device, compatibility with other devices, etc.

10. Risk Management: Design/Production team need to evaluate all risks associated with product and production process. Investigation to identify hazards, estimate risk and identify actions to manage unacceptable design and process risks. Often Document: ◦Potential failures of product ◦Failure’s effect on the consumer and severity ◦Cause of failure ◦Actions to reduce failure or risk occurrence

11. Design Changes Very common Communicate the change Document control department: ◦Documents are properly identified ◦A master list or index of documents is compiled. ◦Govern entry of documents into the document control system (ECO’s) ◦A history of document revisions ◦Procedures for distributing copies ◦Removal and deletion of obsolete documents.

12. Design Validation/Verification: The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the Design History File. Verification ensures that outputs conform to inputs. ◦Tests, inspections, analyses ◦Mechanical testing data, tolerance stack-ups, mathematical models ◦Detailed reports are required to document verification activities. Validation ensures that outputs meet ultimate user needs. -Product should be tested in actual or simulated use environment. -This would include clinical trials if necessary. ((Cadaver Labs)) -Test protocols and acceptance criteria must be documented. -For a complex design, the detailed results may be contained in a variety of separate documents and summarized in a validation report.

13. Device Master Record  Purpose – DMR is a compilation of those records containing the specifications and procedures for a finished device.  Device specifications including appropriate drawings, composition, formulation, component specifications, and software applications.  Production process specifications including appropriate equipment specifications, production methods, production procedures, and production environment specifications.  Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment used.  Packaging and labeling specifications, including methods and process used.  Installation, maintenance, and service procedures and methods.

15. Design Transfer Documentation Once a product has been designed, it must be transferred to the production phase. The manufacturing facility needs detailed production specifications. ◦These include: detailed product drawings, workmanship standards, manufacturing instructions, inspection criteria, heat treat conditions, etc. ◦Comprehensive documentation is required for efficient and high quality production of the product.  One must remember that a different supplier in the future may make the product.

16. Design/Project Review Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

17. DHF SENIOR DESIGN REQUIREMENT A design history file will be required for each groups senior design project. This DHF will be submitted in the Spring semester with the final report

18. SUMMARY ASSUME EVERYTHING YOU HEAR, SAY, THINK, WRITE, READ, AND CREATE IS IMPORTANT! NO MATTER HOW INSIGNIFICANT, TRIVIAL, IRRELEVANT, IMMATERIAL, OR INCONSEQUNETIAL YOU THINK IT MAY BE. RECORD, DATE, SIGN, AND SAVE EVERYTHING! You will be audited!

19. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/G uidanceDocuments/ucm070627.htm#_Toc382720792http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/G uidanceDocuments/ucm070627.htm#_Toc382720792 http://medicaldesign.com/mag/model_device_development_0908/ http://books.google.com/books?id=X1a9fQyKSuQC&pg=PA39&lpg=P A39&dq=design+transfer+documentation&source=bl&ots=coHNb3R DYz&sig=cUvLb6VDHI3dLXu2B9cb9bfjgFs&hl=en&ei=rQXvSvjRPM 6TlAfn4az_BA&sa=X&oi=book_result&ct=result&resnum=2&ved=0C A4Q6AEwAQ#v=onepage&q=design%20transfer%20documentation &f=false