Medical Waste Consulting

Medical Waste Consulting

P&O Advisory Services – Medical Waste Equipment

P&O delivers comprehensive regulatory services to help get your product into the International medical market. You can choose elements of our service or take advantage of our experience to enhance your product development and strategy, your CE Marking and your ISO 13485 quality management system.

Our experienced project consultants can help plan your projects, help predict pitfalls and hurdles, and use their knowledge to indicate which project activities require early attention. Our experienced engineers can assist in product design and implementation. Our regulatory consultants can get you through the red tape. We have experience designing and operating systems to comply with ISO 9000, ISO 13845 and TS 16949.

Medical Quality Systems, Regulatory Compliance, Design Control and Validation

Elements to address when developing your product and producing a Technical File or 510k Submission

  • Development Project Management
  • Standards review
  • Product design
  • Test early prototypes
  • Statement of Claims
  • Essential Requirements Check List
  • Risk Analysis (ISO 14971)
  • Functional testing protocols and test reports
  • Biocompatibility testing
  • Sterilisation validation
  • Drawings, specifications, BOM (bill of materials) and supplier audits
  • Training

Quality Management Systems

  • Process analysis
  • ISO 13845 Documentation
  • ISO 13845 Pre-Audit
  • Internal Auditor training
  • Process implementation

Toxicology

  • Advice on how to apply ISO 10993 and in-vivo functional tests, and when to use material characterisation chemical tests in place of lengthy toxicity testing

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