As the ISO 13485 standard provides a benchmark for medical device manufacturers to plan and manage quality processes throughout the entire product management cycle, ISO 14971 acts as an "addendum standard" that stipulates the planning and administration of risk-management processes within the same environments.
The FDA and many additional regulatory bodies throughout the world recognize ISO 14971 risk management standards as a world class risk management criterion and often audit to the same. In Europe, many regulations have been harmonized to ISO 14971, which makes the standard highly applicable/relevant across the global medical device community.
You may already be aware that the ISO 14971 standard provides key definitions (the standard can be purchased via the iso.org website) regarding general risk management processes. Hazards, harm, risk analysis, risk estimation, risk evaluation, risk assessment, risk control, and residual risk are all terms carefully defined within the standard. There are of course many additional definitions provided within the standard for terms that are useful when developing or improving upon risk management processes.
The standard also provides information regarding the main purposes of risk management (i.e, essentially the overview section) which could be described as 1) hazard identification, 2) risk estimation and evaluation, and 3) the development, implementation and monitoring of risk control measure.
The standard also points medical device quality manufacturers in the direction of establishing a risk management framework which should include:
In addition, the standard also assists medical device manufacturers in specifying intended use, defining the scope of the device, understanding documentation, identifying hazards, defining hazardous situations and foreseeable events, estimating risk, evaluating risk, controlling risk, evaluating risk acceptability, producing risk management reports, and managing information throughout the entire production and post-production cycle.
MasterControl, Inc. provides state-of-the-art EQMS software that streamlines risk management processes electronically and keeps medical device quality and regulatory professionals regularly passing internal and third-party audits quickly and efficiently. MasterControl also provides state-of-the-art consultation services that assist medical device companies as they "train" their risk management processes into top shape in minimal time.
MasterControl also provides all of the document control, document management, and audit management software (included within the EQMS framework) required to manage risk effectively within the medical device environment.
Für weitere Informationen zum Risikomanagement und zu ISO 14971 (oder zu weiteren ISO-Normen), wenden Sie sich bitte an einen MasterControl-Mitarbeiter.