1. Medical Device Design and Development
Design Controls
Andre Routh, PhD

2. Target Audience
Design & Development engineers
Quality Management System personnel
Documentation Control personnel
Regulatory Affairs professionals

3. Product Life-Cycle
Market research
Research
Development
Manufacturing engineering
Manufacturing
Distribution (sales & service)
Product obsolescence and disposal

4. FDA Design Controls
US regulatory requirement for Design Controls is found in 21 CFR :
Code of Federal Regulations (CFR)
Title 21
Part 820
Section 30
Design Controls

5. 21 CFR
“All manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow DESIGN CONTROLS [§820.30] during the development of their device.”

6. 21 CFR
“The DESIGN CONTROL requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution.”

7. Design Control: Definitions
Product
Result of a Process
Specification
Document stating Requirements
Product Specification
Document stating Requirements that results from Design and Development Control process
Design and Development
Set of processes that transforms Requirements into the Specification of a Product

8. 21 CFR 820.30 Design Control Steps
Design and Development Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design History File

9. “Waterfall” Design Process

10. Overview of Design Control
Planning
Determine Customer Requirements
D/D Planning Start of DC Process
Design
Input
Design Planning
Design Review
Design Verification
Design Validation
Design Changes
Outputs: Approved Product Specification, DHF, DMR, Batch record defined, Metrics, Documents, Records 10

11. Verification loop from Design Output to Design Input
Two Feedback Loops
Verification loop from Design Output to Design Input
Validation loop that demonstrates that the medical device satisfies user needs

12. Feedback
In practice, feedback operates at all levels.
A change found necessary later in the process will have effects that ripple both backwards and forwards.
Ripple Effects Analysis
Regression Analysis

13. Verification and Validation
Design Verification – Evidence that the manufacturer made the product right
Design Validation – Evidence that the manufacturer made the right product

14. Design Reviews
Design reviews are held at pre-defined points during the development process.
Additional reviews will be held on an as-needed basis.

15. EU Medical Device Directives
Medical devices for sale in Europe are regulated by “device directives”
Medical Device Directive (MDD 93/42/EEC)
Active Implantable Medical Device Directive (AIMDD 90/385/EEC)
In Vitro Diagnostic Directive (IVDD 98/79/EEC).

16. EU Medical Device Directives
Each directive includes a list of “Essential Requirements” (ERs) that must be satisfied before a device can be brought to market.
One method of demonstrating conformity with the ERs is to use “Harmonized Standards”, which give the presumption of conformity with the ERs.

17. EU Harmonized Standards
Medical Devices
Active Implantables

18. EU Harmonized Standards
Examples:
ISO (QMS)
EN 980 (Labelling)
EN (Biological compatibility)
EN (Packaging)
EN (Clinical Evaluation)
ISO 14971(Risk management)
EN (Medical electrical equipment)
See for a complete listing

19. QMS Standard ISO 13485
ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 13485:1996 Section 4.4 Design Controls. Intent very similar to that of 21 CFR

20. ISO13485 & 21 CFR
Design Control Guidance for Medical Device Manufacturers (March 11, 1997)
“This Guidance relates to FDA 21 CFR and Sub-clause 4.4 of ISO 9001”.
NOTE: ISO 13485:1996 was the medical device version of ISO 9001:1994 to which the guidance refers.

21. Correspondence 1996 & 2003 1996 2003 1 Contract review 4.3.2, 4.4.4
7.2.1 2
D & D planning
4.4.2, 4.4.3
7.3.1 3
D & D inputs
4.4.4
7.2.1, 7.3.2 4
D & D outputs
4.4.5
7.3.3 5
D & D review
4.4.6
7.3.4 6
D & D verification
4.4.7
7.3.5 7
D & D validation
4.4.8
7.3.6 8
Control of D & D changes
4.4.9
7.3.7

22. Design Controls Comparison
D&D Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design History File
D & D planning
D & D inputs
D & D outputs
D & D review
D & D verification
D & D validation
D & D changes

23. Design Dossier/ Technical File
ISO 13485:2003 does not use the phrase “design history file”. However, Section (f) states:
“For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management requirements.”

24. Design Dossier/ Technical File
“These documents shall define the complete manufacturing process and, if applicable, installation and servicing.”
NB-MED/2.5.1/Rec5 provides a good overall model for technical documentation

25. Risk Management ISO 13485:2003 21 CFR 820.30
Section 7.1, Planning for Product Realization requires that the manufacturer “establish documented requirements for risk management throughout product realization”
Section 7.3.2, Design and Development Inputs requires that one of the inputs be the output of risk management.
21 CFR
Risk analysis is mentioned in in the Design Validation step.

26. Inputs to Design Control

27. Outputs From Design Control
Design Control Outputs:
Design History File, Design Master Record, Manufacturing information
Batch record definition
Feedback from the process
Decisions on Outsourcing
Post Market Surveillance on the particular product
Metrics on performance of the process

28. Outputs From Design Control

29. 7.1 Planning Product Realization
The first step once a project has been agreed is to plan the product realization. This occurs before Design Control starts
Planning should take as its input; resource requirements known; overview of the intended project [many times this will take the form of marketing data, competitive data, research information, or other sources which the organization wishes to pursue]; regulatory information

30. 7.1 Planning Product Realization
Planning includes consideration of any new processes needed for Product Realization. This could include production processes, as well as design control processes
In planning, the following should be considered:
Quality objectives and requirements for product
Process and resource needs
Verification, validation, monitoring, inspection and test activities, criteria for product acceptance
Records needed

31. 7.1 Planning Product Realization
Risk Management shall have documented requirements established ‘throughout product realization’….In particular, this requirement does not limit the thinking process to Design Control, but invokes all the other requirements of Product Realization
Risk Management shall be documented and records kept
ISO 14971:2007 is recommended

32. 7.2.1 Determination of Product Requirements
The next step before Design Control is to determine the Product Requirements, basically the Product Specification. The organization shall determine:
Requirements specified by the customer
Requirements not stated by the customer but necessary for intended use
Statutory and regulatory requirements…for the product

33. 7.3.1 Design and Development
The organization shall establish documented procedures…to plan and control the design of the product:
Determine stages
Design review, verification, validation and design transfer appropriate at each stage
Responsibilities and authorities
Planning output is a record, and shall be updated

34. D&D Inputs
Functional, safety and performance requirements, according to intended use
Regulatory requirements
Post Marketing Surveillance (PMS) data, if available
Risk management outputs are inputs to this stage
The design input record must be documented and Approved

35. D&D Outputs
Design Outputs must provide objective evidence the design inputs have been met
Design outputs shall:
be approved prior to release
Provide information for purchasing and production
Contain product acceptance criteria [production V&V]

36. 7.3.3 D&D Outputs Design Outputs can include:
Specifications for raw materials, component parts
Drawings and parts lists
Customer training materials
Process and materials specs

37. 7.3.3 D&D Outputs Finished medical devices specs
Product and process software
Quality assurance procedures
Manufacturing and inspection procedures
Work environment requirements
Packaging and labeling specifications
Identification and traceability requirements
Regulatory authority submissions

38. 7.3.4 D&D Review ‘At suitable stages’ – defined in Plan
‘systematic reviews’
‘participants...shall be those…concerned…with the stage’
Key focus; the PRODUCT
Key question; have we addressed all the REQUIREMENTS

39. D&D Review
Design Reviews shall be conducted in accordance with the Design Plan
Participants shall be competent to evaluate the stage [s] under review
Records….and actions…shall be maintained:
Purpose of review is to evaluate ability to meet requirements and identify problems and discuss and act as needed

40. D&D Verification
Verification shall be performed in accordance with the Plan
Purpose is to confirm that the Design Outputs [which have been documented and approved] have met the Design Inputs [which have been documented and approved]

41. 7.3.5 D&D Verification Verification can include:
Alternative calculations
Comparing a new specification with proven spec
Undertaking tests
Reviewing documents prior to issue
Records….and actions…shall be maintained

42. D&D Validation
Validation shall be performed in accordance with the Plan
Purpose is to confirm that the Product is capable of meeting the requirements for:
The specified application
The intended use

43. D&D Validation
Validation shall be completed prior to delivery of the product
Validation could include:
Clinical evaluations required by regulations
Real or simulated use conditions [completed device]
Records….and actions…shall be maintained

44. Control of Change
Design and development changes shall be identified and records maintained
Changes shall be approved before implementation
Changes shall consider evaluation of impact on product already delivered
Records….and actions…shall be maintained

45. References
1 Code of Federal Regulations (CFR) Title 21, Part 820, Section 30 (21 CFR ) Design Controls
2 ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes
3 ISO/TR 14969:2004 Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003

46. References
4 Global Harmonization Task Force GHTF.SG3.N99-9 Design Control Guidance for Medical Device Manufacturers (June 29, 1999).
Note 1: This document was archived on June 21, 2005 from the GHTF website because it is no longer the most current information available. ISO/TR 14969:2004, in which GHTF SG#3 participated, is considered to be the most current guidance.
Note 2: This document contains the same basic information as Reference 5.

47. References
5 Design Control Guidance for Medical Device Manufacturers relating to FDA 21 CFR and Sub-clause 4.4 of ISO 9001 (March 11, 1997)
6 ISO 13485:1996 Quality Systems - Medical devices — Particular requirements for the application of ISO 9001
7 GHTF web-site:
8 FDA CDRH web-site:

48. Contact André G. Routh, PhD Senior Product Expert
BSI Product Services - Healthcare
Phone/FAX:
Cell: