Risk Management
Your Risk Management Process is the foundation on which your devices’ safety and performance are maintained throughout their life cycle.
Working with you we develop and document your Risk Management Process to meet the requirements of ISO 14971 and specific national regulations.
Using our experience we provide support to prepare, implement and maintain your Risk Management System embracing:
We provide training in Risk Management for Medical Devices (see Training).
Expertise
Applying our methodologies we have implemented effective Risk Management processes & systems, to meet ISO EN 14971 and fulfill country regulatory requirements. With our clients we have prepared, conducted and documented:
- Risk Management Plans
- Hazard Characterisation / Analyses
- Risk Assessment
- Risk acceptance criteria
- Benefit-Risk assessment
- Risk Management Report
For devices such as:
- Stand alone software
- Theatre apparel & drapes
- Wound & surgical dressings
- Combination devices
- Invasive devices
- Long term implantable devices
- Active therapeutic devices
- Sterile & Measuring devices
- Surgical Equipment / Instruments
- Monitoring & diagnostic devices
