Medical Device Manufacturing Validation, Quality, Risk, Regulation, …...

Information & Training. | Medical Devices

Validation of a medical device prior to the device entering the manufacturing process demands an understanding of the applicable regulatory requirements, an evaluation of product and process risks, clear establishment of customer expectations, clarity of business resource capabilities, understanding of quality system requirements, etc., etc.. Applicable standards and regulations will be along the lines of 21 CFR 820, 93/42/EEC, ISO 13485, ISO 14971, 2007/47/EC, MDR (EU) 2017/745, which you need to understand and effectively apply. The first step in any Medical Device Validation process, is to plan your approach to Validation activities.

Medical Device Manufacturing Validation, Regulation, Risk, … Information & Training presentation, >>>

Medical Device Validation – The Master Validation Plan:

• How will risk identification input into the validation process?
• How does device classification impact the validation process?
• What are the applicable regulatory requirements?
• How to ensure compliance with good manufacturing practices?
• What are the Medical Device reprocessing regulations?
• How to optimize the use of statistical analysis in the validation process, … etc…

Within the Master Validation Plan, will the approach to process validation be to treat the validation activities as part of a “life cycle activity”. Will “Quality by Design” be the basis for an acceptable validation process? A risk analysis will need to be applied in order to accurately identify the critical quality attributes (CQA’s) and the critical performance parameters (CPP’s). Will the approach be “Worst Case Analysis”, or will the focus be on true performance qualification rather than on “worst case” validation runs.

Regardless of the approach to Validation, there will need to be a greater focus on monitoring and testing in the early stages of manufacturing, backed-up by an effective quality system for trend analysis and process correction.

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. …
  - Information & Training presentation >>>

Reference sources:
FDA Process Validation – General Principles and Practices
EU Guidelines for Good Manufacturing Practice – For Medicinal Products