Medical Device Design and Development. Validation. Regulation. Control...
Information & Training. | Medical Devices.
When considering medical device design control, you need to consider the US FDA Code of Federal Regulations, the European “CE” Mark based on the Medical Device Directives, the various international regulations on medical device guidance, such as those from Health Canada or from ANZTPA (Australia, New Zealand Therapeutic Products Agency). Here we shall focus on the US FDA Design Controls, outlined in the CFR’s.Introduction.
The medical device design control section of the FDA Quality System Regulation applies to the design of products and processes and changes to existing designs and processes. Changes to existing designs should be made in accordance with design control requirement even if the original design was not subject to these requirements.
FDA treats non compliance with design control requirements in CFR’s the same as non compliance with other provisions of the cGMP regulations.
Why is there a need to focus on design controls?
i) Due to device recall experience – In a study of quality problems, 44% of recalls were due to design deficiencies.
ii) Software related recalls – 90% of software-related failures were design related errors.
iii) It is estimated that within the USA, effective medical device design controls can avert on average 40 deaths and 600 serious injuries per year.
Definitions relevant to medical device design control.
“Design History File” (DHF) means a compilation of records which describe the design history of a finished device.
“Design Input” means the physical and performance requirements of a device that are used as a basis for device design.
“Design Output” means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
“Design Review” means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems
“Device History Record” (DHR) means a compilation of records containing the production history of a finished device.
“Device Master Record” (DMR) means a compilation of records containing the procedures and specifications for a finished device.
“Establish” means define, document (in writing or electronically), and implement.
“Where Appropriate” means it is deemed to be appropriate unless the manufacturer can document justification otherwise.
Quality System Regulation – Design Controls.
General.
Each manufacturer of any class II or class III device, and specified class I devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
Design and Medical Device Development Planning.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
NewEuropean Medical Device Regulations (MDR’s). MDR Classification.
Medical Device Software Validation.
Medical Device Design Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
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Design and development planning.
– Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.
– The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.
– The plans shall be reviewed, updated, and approved as the design and development evolves.
The plan shall ensure that the design process is appropriately controlled and the device quality objectives are met.
Typical Plan Elements Include:
– Description of the goals and objectives of the design and development program; i.e., what is to be developed;
– Delineation of organizational responsibilities with respect to assuring quality during the design and development phase, to include interface with any contractors;
– Identification of the major tasks to be undertaken, deliverables for each task, and individual or organizational responsibilities (staff and resources) for completing each task;
– Scheduling of major tasks to meet overall program time constraints;
– Identification of major reviews and decision points;
– Selection of reviewers, the composition of review teams, and procedures to be followed by reviewers;
– Controls for design documentation;
– Notification activities.
Human Factor Implications of the GMP Rule.
The following are design control excerpts that relate to human factors:
Design input: “Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.”
– Human factor relevance: Manufacturers need a process that ensures adequate consideration of human factors in the design and development of medical devices.
Design verification and validation: “Design validation shall ensure that devices conform to defined user needs and intended uses.”
– Human factor relevance: Meeting user needs, requires that the user-device interface be designed such that it can be operated safely by the users of the device, and that adequate precautions have been taken in the design of the device such that user error is minimized.
Information & Training.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- NewEuropean Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
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FDA Design Control Guidance for Medical Device Manufacturers
European Medical Device Regulation