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Risk management
Our team offers risk management support tailored to meet your needs, whether it’s developing overarching strategies or addressing your specific challenges.
Medical device risk management
Risk management has become central in the medical device lifecycle and is therefore one of the most important tools in the market registration process, since it enables the manufacturer to identify the product safety requirements.
Risk management according to the ISO 14971:2019 standard involves risk identification, estimation, evaluation, control, and monitoring, to ensure the safety and effectiveness of the medical device throughout development, manufacturing, and use of medical devices.
Our team offers comprehensive risk management support tailored to the needs of your company and products, whether it’s developing overarching strategies or addressing specific areas.
We understand the risk management requirements and techniques that relate to other standards that reference ISO 14971, such as:
- ISO 14155 Clinical Investigation
- IEC 62366 Usability Engineering
- ISO 62304; IEC/TR 80002 Software Development
- ISO 10993 Biological Evaluation
- IEC 60601 Medical Electrical Equipment
Examples of services that we provide:
- Supporting efficient execution of risk management activities
- Seamlessly integrating risk management into the quality management system
- Conducting audits of the risk management process
- Conducting audits of the risk management file
- Determination of benefit-risk
- Answering risk management-related questions raised by notified bodies and authorities
- Providing custom or open training sessions
Get in touch with us
Explore our quality and regulatory services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.