Medical Device Design QSR’s
FDA GMP Quality System Regulation
Information & Training. | Medical DevicesThe FDA Medical Device Design QSR’s state that the design process needs to be defined and effectively implemented in order to ensure that the required design specifications are achieved. The design procedures need to cover all functions that impact the final product design. The design specifications need to be clearly defined. As the product progresses through development, the developing product needs to be assessed against the original design specifications during design reviews. These design reviews must include a range of competent individuals who understand the needs of the customer, the environment of potential use of the product, the practicality of manufacturing the product on a consistent basis, the ability to reliably source suitable materials, etc..
When the final design is proposed and deemed acceptable through the various design reviews then the final design needs to be verified and validated. The verification and validation will encompass the full range of resources and inputs that will be required to manufacture and supply the device to the end users.
The Medical Device Design QSR’s state that the process for transferring the product from design and development into manufacturing must be defined.
Where a need arises to change the design specification or device design at any stage through development or manufacture, then there will be defined change control procedures.
A detailed design history file (DHR) will be maintained for the device which will act as a record to demonstrate that the device as developed, meets the design specifications and was designed in accordance with the approved design processes.
Information & Training.
- 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).
- New European 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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