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Clinical 2 – Trials for Medical Devices – The Best Approach

Who should attend

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

  • Regulatory Affairs Professionals
  • Engineering professionals
  • Research/Development professionals
  • Personnel involved in any aspect of the clinical evaluation process
  • Quality Assurance Professionals

Course Outline

Clinical trials, also called clinical investigations, in medical devices have been subject to increasingly stringent regulation in recent years following introduction of ISO14155.

The latest version Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155: 2011) aligns the standards of conduct for medical device trials with those required for the approval of a new pharmaceutical product.

The outcomes of all clinical trials, regardless of specific methodology or the item under investigation, remain constant; a need for consistent, high quality, reliable results, achieved in a timely and cost-effective manner.

This highly practical insight will introduce you to the general principles of good trial design, demonstrating how setting these within the framework of the regulatory standards helps to ensure consistent, meaningful results that can be applied to the wider population of people using the medical device under investigation. The course provides practical requirements of planning and undertaking a Clinical Investigation.

Topics covered

  • Brief history of clinical trials and its impact on ethics
  • General overview of ISO14155: 2011 and its importance for ensuring quality
  • Translating the requirements of ISO14155: 2011 into practical application
  • The concepts of populations and sampling
  • Basic statistical considerations and their impact on a clinical investigation
  • Precision, accuracy and bias: their definition, assessment and control through trial design
  • Safety and effectiveness: the risk:benefit ratio and risk management through ISO14971
  • In the clinic: considerations for patients, investigators and methodology
  • The central importance of patient confidentiality
  • Adverse events: identifying, monitoring and reporting
  • Long-term safety monitoring
  • Handling the unexpected when it happens
  • Special considerations for combination products
  • An appreciation of how ISO14155: 2011 impacts medical device clinical trials
  • A knowledge and understanding of how to design a high quality clinical trial
  • An appreciation of the clinical trial process from design to final report
  • An appreciation of the key role played by the protocol
  • An understanding of the central importance of safety and its assessment
  • Awareness of how results from a trial translate to the wider population
  • An understanding of the inter-relationship between ISO14155: 2011 and ISO14971

Outcomes

  • An appreciation of how ISO14155: 2011 impacts medical device clinical trials
  • A knowledge and understanding of how to design a high quality clinical trial
  • An appreciation of the clinical trial process from design to final report
  • An appreciation of the key role played by the protocol
  • An understanding of the central importance of safety and its assessment
  • Awareness of how results from a trial translate to the wider population
  • An understanding of the inter-relationship between ISO14155: 2011 and ISO14971

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