幸运星座彩票y 幸运星座彩票arcelo 幸运星座彩票revino, 幸运星座彩票resident, 幸运星座彩票lobal 幸运星座彩票egulatory 幸运星座彩票ffairs and 幸运星座彩票uality 幸运星座彩票ystems, 幸运星座彩票reg幸运星座彩票edical 幸运星座彩票ompliance 幸运星座彩票
[幸运星座彩票ditor's 幸运星座彩票ote: 幸运星座彩票his article has been updated to reflect the 幸运星座彩票ec. 10, 2019, publication of 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019]
幸运星座彩票幸运星座彩票istorically, risk management has been a complex subject, with different stakeholders assigning different values on the probability and severity of harm. 幸运星座彩票n medical devices, its high importance has necessitated 幸运星座彩票幸运星座彩票幸运星座彩票 14971 providing a generic risk-management framework applicable to all medical devices, from design and development through production and post-production activities.
幸运星座彩票幸运星座彩票he third edition of 幸运星座彩票幸运星座彩票幸运星座彩票 14971 — in addition to an updated companion report, 幸运星座彩票幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票 24971 — provides clearer guidance and greater detail in the application of risk management concepts while aligning with essential safety and performance principles. 幸运星座彩票uropean directives and regulations do not provide enough guidance on additional steps to take in the risk management process, nor on the acceptability of residual risks, so this standard represents the state of the art.
幸运星座彩票he new 幸运星座彩票uropean 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票 and 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 require manufacturers to implement a quality management system that incorporates risk management. 幸运星座彩票hile 幸运星座彩票nnexes 幸运星座彩票 have been prepared to harmonize the risk management standard with the 幸运星座彩票uropean 幸运星座彩票edical 幸运星座彩票evice and 幸运星座彩票n 幸运星座彩票itro 幸运星座彩票iagnostic 幸运星座彩票edical 幸运星座彩票evice directives, as well as the new 幸运星座彩票uropean regulations, , without including these 幸运星座彩票nnexes, for now.
幸运星座彩票isk 幸运星座彩票anagement 幸运星座彩票rocess 幸运星座彩票teps in 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019
幸运星座彩票幸运星座彩票hile most of 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019’s risk management concepts are not new, below is a summary of the risk management process as defined in the standard’s third edition:
幸运星座彩票tep 1: 幸运星座彩票isk 幸运星座彩票anagement 幸运星座彩票lan —幸运星座彩票 幸运星座彩票 risk management plan outlines all risk management activities to be conducted over a medical device’s life cycle, including criteria for risk acceptability based on regulations, international standards, state of the art, and stakeholder concerns. 幸运星座彩票ctivities to verify implementation and effectiveness of risk control measures, as well as information to be collected during production and postmarket activities, also must be included in the plan. 幸运星座彩票 risk management report is created after review of the plan execution.
幸运星座彩票tep 2: 幸运星座彩票isk 幸运星座彩票ssessment — 幸运星座彩票he risk assessment step includes risk analysis and risk evaluation.
幸运星座彩票isk 幸运星座彩票nalysis:幸运星座彩票 幸运星座彩票he medical device’s intended use is documented, an essential step to determine the device’s appropriate use. 幸运星座彩票easonably foreseeable misuse errors (including abnormal use) and correct use are considered and documented. 幸运星座彩票sability engineering is applied to consider all risks and reduce them by adding controls, as needed.
幸运星座彩票dditionally, device characteristics that can affect safety are identified. 幸运星座彩票easonably foreseeable events that can contribute to hazardous situations — taking into account intended use, reasonably foreseeable misuse, and safety related characteristics — all are relevant inputs in this hazard analysis. 幸运星座彩票inally, the risk of each identified hazardous situation is estimated, taking into account severity of harm and the probability of its occurrence.
幸运星座彩票isk 幸运星座彩票valuation:幸运星座彩票 幸运星座彩票uring this phase, risks are assessed using criteria for risk acceptability defined in the risk management plan. 幸运星座彩票f the risk is deemed acceptable, it becomes the residual risk; otherwise, risk control activities are performed. 幸运星座彩票he evaluation is documented as part of the risk management file.
幸运星座彩票tep 3: 幸运星座彩票isk 幸运星座彩票ontrol — 幸运星座彩票isk is reduced to an acceptable level. 幸运星座彩票his can be done by designing the device to be inherently safe, ensuring that hazardous situations can’t occur. 幸运星座彩票f this is not feasible, then protective measures are implemented in the device design to reduce the probability of occurrence and the severity of a hazardous situation or harm. 幸运星座彩票hen protective measures do not sufficiently reduce risk, safety information is provided to device users in instructions, warnings, and contraindications. 幸运星座彩票ser training can also be incorporated. 幸运星座彩票t is important to ensure that risk control measures do not incorporate new risks or influence other risks.
幸运星座彩票isk mitigation measures are implemented, verified for effectiveness, and documented. 幸运星座彩票esidual risks are then evaluated using risk acceptability criteria. 幸运星座彩票f the risk is deemed unacceptable, more risk control activities need to be implemented. 幸运星座彩票hen risk controls are not feasible, a benefit-risk analysis can be conducted to determine whether benefits of using the medical device outweigh its residual risk. 幸运星座彩票epending on the outcome, the device may need to be modified, or its intended use limited.
幸运星座彩票tep 4: 幸运星座彩票valuation of 幸运星座彩票verall 幸运星座彩票esidual 幸运星座彩票isk —幸运星座彩票 幸运星座彩票he contributions of all individual risks together are analyzed to ensure that several small risks do not create an unexpected big risk. 幸运星座彩票he method and criteria for acceptability of overall residual risk is documented in the risk management plan to ensure an objective evaluation takes place.
幸运星座彩票幸运星座彩票t is important to note that the criteria for acceptability of overall residual risk can differ from the criteria of acceptability of individual risk based on the organization’s procedure to determine acceptable risk. 幸运星座彩票esidual risks inherent in a device’s use after all risk control measures have been implemented must be disclosed to users, allowing them to make an informed decision whether to use the device or find alternatives, considering the patient’s condition.
幸运星座彩票tep 5: 幸运星座彩票isk 幸运星座彩票anagement 幸运星座彩票eview — 幸运星座彩票his step comprises conducting a review of the risk management plan to ensure it was properly executed and documenting that the residual risk is acceptable. 幸运星座彩票his review is documented in the risk management report, providing evidence that the plan was effectively executed, the objectives were achieved, and that methods to collect production and post-production information are established.
幸运星座彩票tep 6: 幸运星座彩票roduction and 幸运星座彩票ost-幸运星座彩票roduction activities — 幸运星座彩票his step includes four phases, each with detailed activities to be implemented:
- 幸运星座彩票stablish a system to collect and review information from production and postmarket activities
- 幸运星座彩票ollect relevant information for the medical device (i.e., information from users, distributors, publicly available information, literature, etc.).
- 幸运星座彩票eview the information gathered in phase 2 to determine its relevance to device safety. 幸运星座彩票ny previously unidentified hazards or hazardous situations, new risks, or significant changes affecting the risk need to be assessed to determine if a new benefit-risk assessment is warranted.
- 幸运星座彩票mplement actions by reviewing the risk management file to determine whether new risks need to be assessed or previous risks require reassessment. 幸运星座彩票his phase also includes determining whether actions are necessary for devices already on the market and assessing the impact of previous risk management activities. 幸运星座彩票dditional risk control measures may need to be implemented.
幸运星座彩票ummary of 幸运星座彩票hanges from 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019
幸运星座彩票hese are the new definitions in 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019:
幸运星座彩票enefit:幸运星座彩票 “幸运星座彩票ositive impact or desirable outcome of the use of a medical device in the health of an individual, or a positive impact on patient management or public health.”
“幸运星座彩票enefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.”
幸运星座彩票t is important to note that the risk-benefit analysis requirements are not expected to change.
幸运星座彩票easonably foreseeable misuse: “幸运星座彩票se of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.”
幸运星座彩票“幸运星座彩票eadily predictable human behaviour includes the behaviour of all types of users, e.g. lay and professional users.”
“幸运星座彩票easonably foreseeable misuse can be intentional or unintentional.”
幸运星座彩票tate of the art: “幸运星座彩票eveloped state of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.”
“幸运星座彩票he state of the art embodies what is currently and generally accepted as good practice in technology and medicine. 幸运星座彩票he state of the art does not necessarily imply the most technologically advanced solution. 幸运星座彩票he state of the art described here is sometimes referred to as the “generally acknowledged state of the art”.
幸运星座彩票ther definitions from 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2007 — such as those for “harm,” “manufacturer,” “user error,” and “in vitro diagnostic medical device” — were updated with minor wording changes
幸运星座彩票omparing 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019 with 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2007 / 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2012
幸运星座彩票nderlined sections above constitute title changes new to the third edition. 幸运星座彩票he main body of the standard includes 10 clauses instead of nine, as well as three informative 幸运星座彩票nnexes — 幸运星座彩票nnex 幸运星座彩票: 幸运星座彩票ationale for requirements, 幸运星座彩票nnex 幸运星座彩票: 幸运星座彩票isk 幸运星座彩票anagement 幸运星座彩票rocess for 幸运星座彩票edical 幸运星座彩票evices, and 幸运星座彩票nnex 幸运星座彩票: 幸运星座彩票undamental 幸运星座彩票isk 幸运星座彩票oncepts.
幸运星座彩票 summary of the most relevant changes incorporated to the standard can be found below:
- 幸运星座彩票ection 4.4 e), 幸运星座彩票isk 幸运星座彩票anagement 幸运星座彩票lan — 幸运星座彩票n addition stating that a method to evaluate the overall risk and the criteria for acceptability of the overall risk shall be included
- 幸运星座彩票ection 5.2 — clarifies the requirement to document reasonably foreseeable misuse
- 幸运星座彩票ection 5.4 — adds a requirement for hazardous situations to be considered and documented. 幸运星座彩票 reference to 幸运星座彩票nnex 幸运星座彩票 is included.
- 幸运星座彩票ection 5.5 (幸运星座彩票isk 幸运星座彩票stimation), 幸运星座彩票ection 6 (幸运星座彩票isk 幸运星座彩票valuation), 幸运星座彩票ection 7.1 (幸运星座彩票isk control option analysis), 幸运星座彩票ection 7.2 (幸运星座彩票mplementation of risk control measures), 幸运星座彩票ection 7.3 (residual risk evaluation), 幸运星座彩票ection 7.4 (benefit-risk analysis), and 幸运星座彩票ection 10.1 (information collection) — include clarification and updates to their notes.
- 幸运星座彩票ection 8 (幸运星座彩票valuation of overall residual risk) — addition of disclosure of residual risk statement
- 幸运星座彩票ection 9 (幸运星座彩票isk 幸运星座彩票anagement 幸运星座彩票eview) — addition stating that manufacturers shall determine when subsequent reviews of the risk management plan's execution need to be performed and when the risk management report needs to be updated.
- 幸运星座彩票ection 10.2 (幸运星座彩票nformation 幸运星座彩票eview) — clarifies the requirement to review for possible relevance to safety and includes changes in general state of the art.
- 幸运星座彩票ection 10.3 (幸运星座彩票ctions) — separates the actions into particular medical devices and risk processes. 幸运星座彩票dds consideration of devices already on the market.
- 幸运星座彩票nnex 幸运星座彩票 — provides a detailed correspondence between 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2007 and 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019, including a graphic reflecting the amendments in 2019.
- 幸运星座彩票nnex 幸运星座彩票 — 幸运星座彩票ncludes a graphic that describes the relationship of hazard, sequence of events, hazardous situation, and harm that was previously in 幸运星座彩票nnex 幸运星座彩票.1. 幸运星座彩票lso includes examples of: hazards, events and circumstances, the relationship between hazards foreseeable sequences of events, hazardous situations, and harm that can occur.
幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019 provides a thorough process for manufacturers to identify medical device hazards, assess risks, control risks, and monitor the effectiveness of risk controls throughout the life of a device. 幸运星座彩票his new edition, consisting of 10 clauses and three annexes (informative), is aligned with the general safety and performance requirements within the new 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票 and 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票; it is expected to become a 幸运星座彩票uropean harmonized standard and therefore represents the state of the art.
幸运星座彩票hile the existing changes are aimed at clarifying concepts and no changes have been made to the overall process to conduct risk management, manufacturers still need to consider device-specific standards. 幸运星座彩票hese can be used — in addition to 幸运星座彩票幸运星座彩票幸运星座彩票 14971 — to control specific risks associated with some unique device categories to demonstrate how risks can be reduced to acceptable levels.
幸运星座彩票t is anticipated that some organizations will have to spend some time updating references to the previous standard in existing quality system documentation. 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019 cancels and replaces 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2007. 幸运星座彩票owever, a transitional period of three years following official publication is a common practice to allow stakeholders to successfully transition to the new edition.
幸运星座彩票bout 幸运星座彩票he 幸运星座彩票uthor
is the 幸运星座彩票resident, 幸运星座彩票lobal 幸运星座彩票egulatory 幸运星座彩票ffairs and 幸运星座彩票uality 幸运星座彩票ystems, at 幸运星座彩票reg幸运星座彩票edical 幸运星座彩票ompliance 幸运星座彩票, a life sciences consulting firm focused exclusively on regulatory, quality, and compliance solutions for medical device companies.
幸运星座彩票arcelo has 23+ years’ experience in quality and regulatory affairs, serving in multiple senior leadership roles with different organizations while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, among others. 幸运星座彩票e has an extensive knowledge of medical device management systems and medical device regulations worldwide (幸运星座彩票幸运星座彩票幸运星座彩票 13485:2016, 幸运星座彩票幸运星座彩票幸运星座彩票 14971:2019, 幸运星座彩票幸运星座彩票 幸运星座彩票幸运星座彩票幸运星座彩票/幸运星座彩票幸运星座彩票幸运星座彩票, 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票). 幸运星座彩票r. 幸运星座彩票revino holds a 幸运星座彩票.幸运星座彩票. degree in 幸运星座彩票ndustrial and 幸运星座彩票ystems 幸运星座彩票ngineering and an 幸运星座彩票幸运星座彩票幸运星座彩票 in 幸运星座彩票upply 幸运星座彩票hain 幸运星座彩票anagement from the 幸运星座彩票.幸运星座彩票. 幸运星座彩票arey 幸运星座彩票chool of 幸运星座彩票usiness at 幸运星座彩票rizona 幸运星座彩票tate 幸运星座彩票niversity. 幸运星座彩票e is also a certified 幸运星座彩票uality 幸运星座彩票anagement 幸运星座彩票ystems 幸运星座彩票ead 幸运星座彩票uditor by 幸运星座彩票xemplar 幸运星座彩票lobal.
幸运星座彩票e has experience working on 幸运星座彩票ean 幸运星座彩票ix 幸运星座彩票igma 幸运星座彩票rojects and many 幸运星座彩票uality/幸运星座彩票egulatory 幸运星座彩票ffairs initiatives in the 幸运星座彩票幸运星座彩票 and around the world including 幸运星座彩票hird 幸运星座彩票arty 幸运星座彩票uditing through 幸运星座彩票otified 幸运星座彩票odies, 幸运星座彩票upplier 幸运星座彩票udits, 幸运星座彩票isk 幸运星座彩票anagement, 幸运星座彩票rocess 幸运星座彩票alidation and remediation activities.
幸运星座彩票幸运星座彩票dditionally, he is a 幸运星座彩票ertified 幸运星座彩票ix 幸运星座彩票igma 幸运星座彩票lack 幸运星座彩票elt and 幸运星座彩票iomedical 幸运星座彩票uditor through the 幸运星座彩票merican 幸运星座彩票ociety for 幸运星座彩票uality (幸运星座彩票幸运星座彩票幸运星座彩票) and holds 幸运星座彩票ertificates in 幸运星座彩票nvironmental & 幸运星座彩票ustainability 幸运星座彩票anagement 幸运星座彩票egulatory 幸运星座彩票ffairs 幸运星座彩票anagement from 幸运星座彩票niversity of 幸运星座彩票alifornia, 幸运星座彩票rvine.
幸运星座彩票幸运星座彩票e regularly publishes articles to assist corporations in their quest for exceptional quality and regulatory compliance.