RISK MANAGEMENT UNIQUE TO YOUR MARKETS, YOUR PRODUCTS, YOUR NEEDS
Risk management is an essential function of the medical device product life cycle and also touches the laboratory and test and measurement industries from a standards perspective. In the medical device industry, it is also prescribed by global regulators through standards, directives, orders and laws.
When thought through and integrated as part of the product development process, risk management serves to protect the patients, caregivers and the business itself.
There are several scenarios where risk management is critical.
As the global marketplace expands, the ability to thoroughly assess sourcing risks in new and existing supply chains is critical. UL helps businesses factor sustainability and social responsibility into their sourcing decisions.
UL helps clients identify and manage supply chain risks with in-depth business intelligence, including global and country risk indices, dynamic risk assessment tools, emerging markets research and onsite risk assessments.
UL’s human factors engineering (HFE) experts support developers of medical, combination and pharmaceutical devices by helping them develop methodologies to reduce use-related risk, including modifying a hardware or software user interface, introducing warnings, and enhancing user documentation and training.
Our experts in use-related risk analysis apply multiple analysis techniques to identify potential use errors and assess their likelihood and severity en route to determining an overall risk level.
Our human factors engineering (HFE) team can support almost any product’s risk assessment. Our experts identify the potential risks up front through an independent third party with experts in the field of HFE who can assess products objectively.
Connected devices come with their own unique risks, depending on the type of connection, the environment and the type of data being shared. UL’s team includes software experts who can assist in identifying potential risks and work with you to put in place the safeguards to protect your data and help assure your product will function as intended in the markets you need.
We assess processes for risk management (required by IEC 60601 Third Edition and the referenced ISO 14971) and quality management systems (required by ISO 13485) to determine any gaps that may exist with similar related requirements in the RoHS II Directive. When completed, a report will be provided identifying process and procedure gaps to the RoHS II Directive. It is the intent that this information may be used as a guide for modification of existing processes so that they may be utilized for the new requirements of RoHS II, thereby minimizing overall requirements for resources and expenses.
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