Medical Device Regulations during Design & Development.
Design Output. Design Review.Design output.
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.
Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.
Design output shall be documented, reviewed, and approved before release.
The approval, including the date and signature of the individual(s) approving the output, shall be documented.
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 labelling, and the device master record.
Design Output Comments.
The quality system requirements for design output can be separated into two elements: Design output should be expressed in terms that allow adequate assessment of conformance to design input requirements and should identify the characteristics of the design that are crucial to the safety and proper functioning of the device. This raises two fundamental issues for developers:
– What constitutes design output? An item is design output if:
it is a work product, or deliverable item.
a design task listed in the design and development plan.
the item defines, describes, or elaborates an element of the design implementation.
– Are the form and content of the design output suitable?
Design Output Examples.
Descriptive materials which define and characterize the design.
– Block diagrams
– Flow charts
– Software high-level code
– System or subsystem design specifications
Production specifications include drawings and documents used to procure components, fabricate, test, inspect, install, maintain, and service the device, such as the following:
– assembly drawings
– component and material specifications
– production and process specifications
– software machine code (e.g., diskette or master EPROM)
– work instructions
– quality assurance specifications and procedures
– installation and servicing procedures
– packaging and labelling specifications, including methods and processes used.
– the results of risk analysis
– software source code
– results of verification activities
– bio-compatibility test results
– bio-burden test results
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).
Design Review Purpose.
In general, formal design reviews are intended to:
– provide a systematic assessment of design results, including the device design and the associated designs for production and support processes;
– provide feedback to designers on existing or emerging problems;
– assess project progress; and/or
– provide confirmation that the project is ready to move on to the next stage of development.
Number and type of reviews.
The number depends on complexity.
Control of the design review process is achieved by developing and implementing a formal program consistent with the QSR’s.
Procedures should detail resolution of concerns and tracking of corrective actions.
Early reviews deal with design input requirement, followed by evaluation of solutions to design issues, then material & manufacturing method related and finally verification, validation & production issues will dominate.
Information & Understanding.
- 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. …
- Information & Understanding >>>
FDA Design Control Guidance for Medical Device Manufacturers
European Medical Device Regulation