Risk Management

Risk Management

Risk Management is an essential part of Quality Management and regulatory compliance and should be integrated into relevant processes across R&D, Operations and Quality.
I have extensive experience with both product and process Risk Management in regulated life science environments and can support organisations in establishing, improving and applying risk-based approaches in practice.

Areas of Support

I can support organisations with:

  • Product Risk Management
  • Process Risk Management
  • FMEA facilitation and documentation
  • Risk assessments related to changes
  • Supplier and outsourced process risk assessments
  • Establishment and improvement of Risk Management processes
  • Integration of Risk Management into Quality Management System processes
  • Training and facilitation of cross-functional Risk Management activities

Product Risk Management

Within Medical Devices and IVD, I have experience supporting Risk Management activities as part of Design Control and related lifecycle activities.
This includes working with cross-functional teams to identify hazards, evaluate risks, define appropriate risk controls and ensure that Risk Management activities are appropriately documented and integrated with relevant Design Control documentation.

Process Risk Management

I also have extensive experience with Risk Management related to manufacturing and operational processes.
This includes facilitation of process FMEAs, identification and evaluation of process risks, definition of appropriate controls and follow-up of risk reduction measures.
My experience covers a wide range of manufacturing and packaging processes and enables me to facilitate Risk Management activities together with Operations, Engineering, Quality and other relevant functions.

Integrated Risk Management

Risk Management should not be an isolated activity.
I focus on integrating risk-based thinking into relevant Quality Management System processes such as Design Control, change management, supplier management and other activities where risk assessment supports effective decision-making.
The objective is to ensure that the level of control and documentation is proportionate to the actual risk and that Risk Management is applied in a practical and consistent way.

Regulatory and Quality Frameworks

My experience includes Risk Management activities in accordance with:

  • ISO 14971
  • ISO 13485

These standards support compliance with applicable MDR and IVDR requirements related to Risk Management.
If you would like to discuss a Risk Management challenge or a potential assignment, you are welcome to contact me.