Medical Device Design & Development.
Verification, Validation, Design Transfer, Design History File, … …Design Verification.
“The manufacturer shall establish and maintain procedures for verifying the device design. Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Design verification shall confirm that the design output meets the design input requirements. 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 activities are conducted at all stages and levels of the device design.
The basis of verification involves a three-pronged approach involving:
– inspections and
Each manufacturer shall establish and maintain procedures for validating the device design. Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s). Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the Design History File. Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
– Not all devices require clinical trials but all require clinical evaluation.
– Tested under actual/simulated use conditions.
– Use testing, inspection, literature search, historical evidence,
– Pilot product OK, but should simulate actual manufacturing process.
– Should include exposure to; shipping, temp, RH, shock, corrosive atmosphere, sterilization, etc.
General principles of software validation guidance.
Unless specifically exempted in a classification regulation, all medical device software developed, regardless of its device class, is subject to the applicable design control provisions of 21 CFR 820. This includes completion of current development projects, all new development projects, and all changes made to existing medical device software. Specific requirements for validation of device software are found in 21 CFR 820. In addition, formal design reviews and software verification are integral parts of an overall software validation, as required by 21 CFR 820.
Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications. Transfer procedures should address:
– First, the design and development procedures should include a qualitative assessment of the completeness and adequacy of the production specifications.
– Second, the procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved.
– Third, the procedures should ensure that only approved specifications are used to manufacture production devices.
Design History File (DHF).
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. A central file or referenced locations should contain:
– A detailed design and development plan specifying design tasks and deliverables.
– Copies of approved design input documents and design output documents.
– Documentation of design reviews.
– Validation documentation.
– When applicable, copies of controlled design documents and change control records.
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. Center for Devices and Radiological Health.