Risk Management

Risk management is one of the key tools required for evaluating consumer safety whilst using a company’s products or services.  A robust risk management process will ensue that the customer needs are defined, the product or service is designed to meet those needs and a process is applied that is consistently capable of producing the defined requirements. For a risk-based approach as nowadays demanded for medical devices and combination products not only be the EU or the FDA, the development team should focus on risk management as early as during the concept phase of the product or service life cycle. Especially during teh development phase, risk management practices can be successfully implement strong statistical techniques and thus, further strengthen the safety profile of the product or service. Risk management is further a key activity applied to product portfolio generation and strategic decision making.

Based on Technical and International standards for risk management (ISO 14971, ISO 31000, etc), Avanti Europe’s Experts guide savvy through standards and regulations. Because of many years of both practical and theoretical experience in the facilitation of risk management, we can support with results-driven knowhow at the client. The use of a robust risk management activity will prevent errors both in product and process design and Avanti Europe’s team can assist in the development of a bespoke risk management strategy.

Expertise and Experience in Risk Management:

  • Failure Mode and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Preliminary Hazard Analysis (PHA)
  • Hazard Analysis and Critical Control Points (HACCP)
  • Medical device risk management (ISO 14971)
  • Combination products risk management (ISO 14971 and ICH Q9)
  • Pharmaceutical risk management (ICH Q9)
  • Software risk management (IEC 62304)
  • Health software risk management (IEC 82304)
  • Enterprise risk management (ISO 31000)
  • Developing and implementing bespoke risk management procedures and processes
  • Customer-specific training (in-house or as e-Learning)

We have supported:

  • Risk-based approach for medical device new product development
  • Risk-based approach for combination product new product development
  • End-to-end risk based approach for combination product remediation
  • Risk Management File maintenance
  • Manufacturing line risk assessments
  • Transport risk assessments
  • Phytopharmaceutical risk assessment and environmental impact assessment
  • CO2 impact assessment
  • Established risk-based process for strategical decision making
  • Risk-based portfolio management

Why Avanti Europe is the right address:

For Risk Management, Avanti Europe is the right address as we hold the following critical certification and skill sets:

  • Decade-long experienced Risk Managers
  • Pragmatic approach to complex and hierarchically structured risk management files
  • Goal oriented
  • Bespoke service and timely delivery of results
  • Interdisciplinary network of experts

Contact us to explore our skill-set and discuss your projects or ad-interim staffing needs.