Risk Management

“The greatest risk is to take no risk”

Risk Management Consulting Services

Risk must be evaluated within the proper context, in comparison to benefits. Consulting services may include risk assessments, risk analysis and risk management planning, risk evaluations, planning recommendations, business strategy and preparation of risk report and documentation. ISO 14971 risk management guidance consulting, FDA risk management guidance for class I, II and II medical devices, pharmaceuticals (drugs), dietary supplements (botanicals, alternative medicine, etc) and IVDs. FTA, FMEA, HFE FRA studies, safety and effectiveness, verification and validation studies.

FDA

The FDA’s risk management initiative seeks to reduce risks to public health. The FDA manages medical product risks throughout the life cycle. Scientific analysis must weigh the risk-to-benefit profile of a medical/pharmaceutical product.

ISO

ISO 14971 provides a guideline for risk management. Medical devices manufacturing companies must have their risk management systems audited and certified by registrars.

Risk Management Consulting Specialties:

  • Medical device, drug (pharmaceutical) and dietary supplement risk evaluation per FDA and ISO guidelines
  • ISO 14971:2000: Application of risk management to medical devices.
  • ISO 13485 quality systems implementation (registration, audits, certification)
  • Risk analysis and risk management system assessment
  • HACCP – Hazard Analysis and Critical Control Points
  • HAZOP – Hazard Analysis and Operability Analysis
  • Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA)
  • Human Factors Engineering (HFE/HF)/Analytical and Empirical HFE Methods
  • Use-related hazards
  • Risk assessment and mitigation/control of use related hazards
  • Validation and verification of user interface designs
  • FRA-Functional Risk Analysis, BS7799 IT Risk Assessment and NIST SP800-30 Risk Assessment
  • Integrated validation documents
  • US FDA 21 CFR Part 11 (GLP, GCP and GMP) / Good Lab, Clinical and Manufacturing Practices
  • CSV – Computerized System Validation
  • IVD In Vitro Diagnostic medical device risk analysis per ISO14971
  • Risk Guidelines and Compliance Standards
  • Risk Management Documentation: Studies, Reports, Procedures and Checklists to properly assess, analyze and manage risks
  • Implementation of Risk Management Techniques, Strategies and Programs
  • Design Input, Verification and Validation
  • Risk and Hazard Identification and Mitigation
  • ISO Quality Standards Implementation, Registration and Certification. Process Control.
  • Risk management audits, systems and standards
  • Class I, II and III Medical device risk analysis
  • Human Clinical Trials
  • Operational risk management training classes
  • Consumer safety
  • Verification and Validation of Final Device Safety and Effectiveness
  • Usability and Safety Testing, Human Factors and Errors
  • Risk managment plans, review, evaluation and implementation
  • Pharmacovigilance: European Medicines Agency (EMEA) and NCA
  • Safety and Effectiveness of Drugs, Biologics, Food Additives and Medical Devices
  • Monitor Safety of Medical Products on Market, through entire life cycle, from production through distribution and use
  • FDA Communication with Advisory Committee and Auditors (Audit Preparation)
  • General Healthcare, Pharmaceutical and Medical Device Industry Regulatory Affairs and 510(k) Notifications
  • FDA MAUDE User Facility Device Experience Database
  • Identify risks, assess risks, analyze risks, implement risk controls, make risk control decisions

Useful Risk Management Information

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