Do human factors matter in medical devices?

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual, physical and sensory forms of human knowledge. Both the ways in which these elements are used to enhance production, as well as the limitations inherent into them are factored in. In essence; human factors deal with how humans and devices or machines interact with each other.

Since human factors places the human mind at the center; design and aesthetics play a very prominent role in this discipline. Being an important element of user interface; human factors and user interface have risen in prominence after the explosion of the field of IT. It however, can be put into use in several other areas. The user being the fulcrum of any area of production; human factors has the potential to be a major factor in creating and shaping user interface for a range of products.

Use in medical devices

Do human factors matter in medical devices

How about the area of medical devices? We have seen that user interface and aesthetics are core ingredients of human factors. Are these the major determinants for the field of medical devices? Yes and no. Yes, because the user is of critical importance in medical devices. A wrong instruction or wrong usage can severely compromise the use of medical devices and can go the extent of even causing harm to the user.

No, because when it comes to another equally important element of human factors, namely aesthetics, the interplay between medical devices and human factors may not appear so pronounced. Yet, while role of aesthetics may not be all that critical to medical devices; there is a related aspect, and that is design.

The role of design is very prominent when it comes to the user interface of medical devices since medical devices have to be designed to absolutely precise specifications. Even small deviations or variations can result in harm to humans. Both the patient and the organization manufacturing the devices need to face consequences as a result of these.

As far as medical devices are concerned, the FDA is tasked with regulating them for ensuring their safety and effectiveness. The incorporation of the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. It is because of these factors that human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations on human factors in medical devices

FDA_s regulations on human factors in medical devices

Under 21 CFR 820.30; the FDA emphasizes that human factors need to be taken into consideration for the following:

  • Design input: To ensure that the needs of the patient and any others who may use the product are taken into consideration

 

  • Design verification: To make sure that the criteria for performance set for the medical are being consistently met, and

 

  • Design validation: To safeguard that the device conform to predefined user needs as well as intended uses, and to also sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

The FDA has also been placing emphasis on human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Full learning on human factors in medical devices

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer complete learning on human factors in medical devices.

Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA, will be the Director of this seminar. To gain knowledge of how human factors related to medical devices, please register for this seminar by visiting Do human factors matter in medical devices? This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products.

Virginia will cover the following areas at this seminar:

  • Overview of Human Factors and the FDA perspective
  • Human Factors Methods and Device Product Life Cycle
  • Human Factors and Risk Analysis & Management
  • Human Factors: What Devices Require Human Factors Evaluation and Validation?
  • Human Factors and Combination Products
  • Human Factors and Combination Products Submitted in an ANDA.

 

 

 

Seminar Calendar of Upcoming Courses – June to July – 2017

Upcoming-Courses-for-French-Circles-Club

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

Rising in one’s career through leadership management

Being a manager is an exercise in continuity. One does not become a manager and stop there. It is important to be, than to become managers. This means that management is a journey, not a destination. Because of this, continuous improvement is needed into this discipline from time to time.

Leadership management is needed to improve both the manager’s own self, and with it, the growth of the organization. Leadership management may be defined as the means by which one identifies, manages and sharpens one’s leadership capabilities. Why leadership management matters for organizations is that when leadership management is developed and refined with the right coaching, it can bring about tremendous change in the managers individually, for the whole team, and in the organization as a whole.

Leadership management is a tool for any ambitious manager

No manager who is ambitious likes to be left behind. It is the desire and ambition of any go-getting manager to stay ahead of her peers. The ways of doing this keep playing in the mind of any ambitious manager. Leading from the front and making a difference to her organization is always a priority for such self-driven managers.

Advancing professionally in one’s career and developing leadership management skills also give most managers a better grip on many practical aspects of management, which are not normally found in textbooks. The delicate performance conversations that they need to have from time to time with employees and the intention of making a difference by being able to coach their mentees more effectively, purposefully and with a strong sense of focus, are some of these.

Self-improvement and improvement for the organization

Leadership management brings about a sense of self-improvement of management skills, right up to the point of motivating the team to do the same on a daily basis. All this should reflect in improved positive results for the organization.

While all these are true; what is also equally true is that most managers hardly find the time to advance their careers. In keeping their sights on the managerial peak; most managers lose sight of leadership management and dilute their purpose. The culture in most organizations –that of getting things done in order to show results –is to blame for this.

In the process of working all the time to just show numbers; most managers lose sight of the more important goal of self-development, which often is at the core of leadership management. Advancing one’s own professional stature is the hallmark of leadership management and is as important as showing results for the organization. After all, a well lubricated, well-oiled managerial staff is the cog in the organization’s wheel.

Advancing within one’s own self as a manager by developing leadership management skills is extremely important, because a manager who is not growing from within cannot take the organization forwards. How does this happen? What are the ways by which managers can bring about leadership management? Is there an effective way of addressing issues concerning leadership management? What are the ways of improving it for the manager’s own good, which will result in benefits for the organization?

A complete understanding of leadership management  

All these will be part of a highly valuable, extremely interactive and entertaining session on leadership management. A two-day seminar on leadership management from GlobalCompliancePanel, a leading provider of professional trainings in all the areas of regulatory compliance, will show how to grow within the organization by focusing on leadership management.

This seminar will offer enjoyable lessons on management and self-improvement to such an extent that the participants laugh, listen and learn with the extremely lively Director of this seminar on leadership management, Chris DeVany.

To derive the immense benefit this seminar is going to impart, please register by visiting Rising in one’s career through leadership management .

Chris, the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organizational development; will lead participants though all these important topics and the key leadership management questions and answers that need to be addressed effectively if the manager has to play a major part in improving the team’s performance overall, as well as that of each member of the team.

An extremely useful session on leadership management

This seminar will be of immense use to all seekers of leadership management, as it will cover all the important aspects of leadership management. Peer discussions addressing leading and managing, integrating finance and quality, managing one’s time effectively, managing performance and managing up, are some of these.

Participants will be able to gain the following lessons on leadership management at the end of this highly useful session:

–       Lead and manage

–       Integrate finance and quality into their organization

–       Manage their time, including prioritizing

–       Manage performance

–       Understand behavioral styles, so they can manage more effectively

–       Handle performance conversations, especially difficult conversations

–       Coach with purpose and focus

–       Manage to Action Plans, both by the team members and oneself

–       Build teams

–       Integrate performance improvement and quality improvement

–       Manage one’s own manager, manage up.

Advanced human resources and employment law

Advanced human resources laws are in the offing, following the swearing in of the new President in the US. The new administration is expected to bring about a number of changes. With the firm accent of the new administration on curbing immigrant workforce, changes that could impact organizations in a number of ways can be expected to take place over the new few months.

Human resources will be the area in which these changes will strongly impact. Carrying out these changes requires making changes into employment laws. Advanced human resources and employment law will need to be implemented, because as a result of these changes into employment laws, uncertainties are expected to creep in in a number of areas of human resources. The new president has made no secret of his intentions to protect small businesses. Although not everything is clear at this stage yet, there is no doubt that changes are sure to come in.

The EEOC’s record monetary damages

While changes are to be expected of any new administration that takes charge, another existent factor could also fuel the need for grasping and implementing advanced human resources and employment law:

Employment lawsuits continue to be on the rise. In 2016, the Equal Employment Opportunity Commission (EEOC) reached the highest collection in monetary damages in its history, touching over $370 million. The EEOC has also been reporting a consistently high, record number of claims being filed by employers in the last three years.

Result of lack of understanding of advanced human resources and employment law

Employers who are not properly equipped for workplace issues and are lacking in the knowledge of advanced human resources and employment law are in greater trouble, as they could face any of these as a result:

o  Discrimination suits

o  Morale issues

o  Litigation

o  Lawyer fees

o  Employee turnover

o  Unplanned expenses

o  Settlements

o  Possible negative community image.

Thorough knowledge of advanced human resources and employment law

Any organization that wants to avoid any of these scenarios needs to have thorough and proper knowledge of advanced human resources and employment law. A two-day seminar on advanced human resources and employment law is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, to help companies prepare for the new administration, to maintain employment law compliance, as well as help avoid litigation.

The Director of this seminar is Vanessa G. Nelson, founder and President of award-winning Expert Human Resources. Vanessa has successfully saved businesses hundreds of thousands of dollars, streamlined multiple processes, and helped develop work teams.

Professionals whose work gets affected by employment laws, such as CEO, COO, Directors, Business Owners, HR Representatives, Managers, and Supervisors can derive the full benefit of Vanessa’s rich and varied experience by enrolling for this seminar. Registration for this event can be made at http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900896?Wordpress_SEO.

To avoid the high cost of employment lawsuits

No matter whether it is in a medium sized company or a large corporation that an HR professional works; the knowledge of advanced human resources and employment law and HR practices is essential to make the business successful. This is because these professionals come across a strikingly large and varied number of employment laws/issues that they have to be aware of.

Over the two days of this seminar, Vanessa will explain to participants the ways by which to deal with confusing human resource situations and how to apply employment laws correctly. She will offer clarity on the many advanced human resources and employment laws.

Other heavy costs of noncompliance with advanced human resources and employment law

The importance of this learning can be ascertained from the fact that the average lawsuit is $165,000, excluding lawyer fees. Employers may have to shell out an additional million dollars or more for a case that goes to trial. Not only is the cost of litigation damagingly high; there is a bigger cost attached to noncompliance, which results from lack of knowledge of advanced human resources and employment law: A jail term.

All these make the knowledge of advanced human resources and employment law all the more necessary. Attendance at this seminar will be valuable in helping gain the critical understanding needed of advanced human resources and employment law.

http://www.mondaq.com/unitedstates/x/554098/employee+rights+labour+relations/Labor+And+Employment+Law+Under+The+Trump+Administration+A+Brief+Overview+For+Colorado+Employers

https://www.skadden.com/insights/trump-expected-to-alter-labor-laws-policies