Quality System Regulations – Purchasing QSR’s.
Information & Training. | Medical DevicesThe FDA Purchasing QSR’s – The quality and reliability of raw materials, component parts, contracted services has a direct impact on the quality, safety and efficacy of the end medical device. Therefore, the same level of controls would be expected to be applied by a supplier or contractor within their respective processes, as the device manufacturer would themselves apply. The FDA expect to see strong controls exercised on product and service providers. These controls will be applied by the manufacturer, who will maintain evidence of such controls.
The process for selecting, evaluating, approving and monitoring product and service suppliers that could impact device quality needs to be defined, documented and implemented.
Full supplier histories need to be maintained.
For all products and services to be provided, clearly defined specifications need to be approved and provided to the suppliers. Where a supplier requests to provide a product or service at variance to specified requirements, or wishes to change the defined requirements, then all such changes need to go through an approved change management and control process. Again records need to be maintained of all such changes.
Where a supplier intends to implement a change within their internal processes, the supplier needs to notify the device manufacturer and an assessment needs to be made of the potential impact on device quality. This supplier requirement, should be defined in supplier documentation. The scope of this requirement should be agreed with the supplier in advance as not all supplier change could impact device quality.
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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