Facts – Until You Reach Your the New EU Medical Device Regulation

The Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.

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The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

-> Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

  • Clinical Trial Managers
  • Regulatory Affairs
  • Medical Officers
  • The updated Regulation
  • Implementation Dates and Transition
  • Main changes and Products Affected
  • Effect on Medical Device Manufacturers

New EU Medical Device Regulation

Effectively Dealing with Harassment and Its Relationship to Discrimination, Retaliation, and Hostile Work Environments

In any case of workplace harassment, an employer’s behavior must meet a certain standard in the eyes of the law. Just posting an anti-harassment policy, while a positive step, is insufficient to prove that an employer took workplace harassment seriously.

Workplace harassment isn’t limited to sexual harassment and doesn’t preclude harassment between two people of the same gender. The harasser can be a boss, a supervisor in another department, a co-worker, or even a non employee. The victim doesn’t necessarily have to be the person being harassed; it can be anyone affected by the harassing behavior.

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Harassment can also be considered a form of employment discrimination under various federal, state and local laws. In order to be considered discrimination, the harassment must be based on some protected trait. Under federal law, those traits include race, color, national origin, gender, pregnancy, age, religion, disability, and genetic information. Many state and local governments have enacted similar anti-discrimination laws.

Retaliation claims are costly and time-consuming for employers. Missteps in handling sensitive employee issues could result in the organization writing a check with a lot of zeros.

Additionally, workplace harassment may constitute a hostile work environment. Some conduct can be so severe on its own that even one incident can create a legal claim of workplace harassment.

How companies investigate potential misconduct can affect the company’s reputation as well as its bottom line.  Because cultural and generational diversity is changing the landscape of the U.S. workforce, that diversity can become fuel for all types of litigation. Understanding how to recognize harassment and effectively conduct workplace investigations can greatly reduce the chances of an organization being sued.

An employer can avoid or reduce liability by taking appropriate preventative measures. Participants will learn the best practices employers can employ to minimize the likelihood of retaliation violations.

Employers first need to understand exactly what harassment is: unwelcome conduct from a boss, coworker, group of coworkers, vendor, or customer whose actions, communication, or behavior mocks, demeans, puts down, disparages, or ridicules an employee. Physical assaults, threats, and intimidation are severe forms of harassment and bullying.  Harassment may also include offensive jokes, name-calling, offensive nicknames, pornographic images on a laptop, and offensive pictures or objects. Interfering with an employee’s ability to do his or her work also is considered a form of harassment.

Employees can also experience harassment when they are not the target of the harasser because of the negative work environment that can develop because of the harassment. This is referred to as a hostile work environment. Additionally, workplace harassment can result in claims of discrimination and retaliation.

Employers often overlook the importance of promptly investigating complaints of harassment and taking quick and appropriate corrective action. Since an employer’s prompt and effective response to complaints can limit or eliminate its liability in a discrimination, harassment, or retaliation lawsuit, it is imperative that employers implement an effective mechanism to investigate and resolve workplace complaints.

Charges of harassment in the workplace can result in costly consequences for companies. In 2017, the EEOC handled 84,254 charges and secured more than $125 million for victims of harassment and discrimination in private, federal, state, and local government workplaces.

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Environmental, Health and Safety (EHS) Management and Audit

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An environmental, health and safety (EHS) management and audit program is now a prerequisite for organizations in various kinds of business. Allied to the emergence of and developing along with the concepts of worker safety and corporate social responsibility; the environmental, health and safety audit is today a major component of an organization. Organizations that need visibility and are desirous of earning a good name should make the environmental, health and safety management and audit a part of their culture.

The practice of companies auditing their environmental, health and safety (EHS) began in the 1970’s, almost contemporaneously with the enactment of OSHA. Around that time, the environmental issue was gaining ground in the corporate circles of the West with the governments and other agencies pitching in with their efforts to create greater awareness of the impact of business activities on the environment. As a result, the thinking that the top management of an organization needs to be viewing this issue more seriously started to develop and got ingrained over the years.

Cannot be glossed over
environmental-health-and-safety-management-and-auditAs a result of various legislations on the issue of environmental safety; the role of the Board of Governors became central in ensuring this aspect of the business. Environmental health and safety was no longer something that needed to be administered superficially, but in formal and designated ways, more specifically in the form of an audit. In order to incentivize corporate entities to implement environmental health and safety (EHS) management and audit; the trend started moving towards making these activities carry value addition to the organization.

Environmental health and safety management and audit is now a more formalized activity that needs to be carried out in a proper, set and well-defined manner. The processes that go into the EHS management and audit are clearly laid out in the form of standards such as the ISO 14001 standard, which is essentially an Environmental Management System (EMS) audit. To strengthen and enrich the audit activity and round it better; a few related and parallel standards such as the relevant parts of the 9000 family of standards, which deals with quality management, and 18000 series audits can be carried out with ease to supplement the environmental, health and safety audit.

Role of environmental health and safety (EHS) management and audit
environmental-health-and-safety-management-and-auditEnvironmental health and safety (EHS) management and audit have now evolved into being a practice that is coupled with and fused into many business-related activities. The practice now is to make an environmental health and safety management and audit an inseparable part of the Quality Management System. Environmental health and safety (EHS) management and audit audits are now a sure means to ensure that the organization has a reputation for corporate social responsibility by implementing this audit.

Aspects of an environmental health and safety management and auditThe aim of environmental health and safety management and audit is to instill the EHS right from the top management down to the line level employee. A properly carried out EHS management and audit system should ideally take these factors into consideration:

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200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Business Process Management in Healthcare helps reduce inefficiencies

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For many years before the advent of automation and computerization ,healthcare processes, such as billing, admissions, and many elements of care were carried out manually. Although it was a capable method to quite an extent, it relied on the use of the manual process or the human method. This was always prone to mistakes and errors, because humans are prone to committing errors that can creep in even with the best of intentions, as a result of which the healthcare industry ended up losing billions of dollars that could otherwise have gone into meaningful forms of investment.

A result of technological developments

This is why Business Process Management (BPM) in Healthcare came into existence with the advent of and as a byproduct of automation. Business process management in healthcare is being considered a major step in helping healthcare settings reduce costs and inefficiencies. When a unit implements business process management in healthcare; there is an automatic reduction in errors and inefficiencies. Let us see how:

Impetus from the higher authorities

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There is now a general tendency and effort to push for automation in the healthcare industry. Even the American Congress has been aggressively pushing for reforms in the healthcare industry, a prime feature of which is fostering business process management in healthcare. Overall, BPM in healthcare is a means for improving efficiencies throughout the healthcare chain and bringing about greater integration and accountability through automation.

Core areas of business process management in healthcare

Business process management in healthcare is useful across the healthcare process chain, but is particularly so in at least there important areas:

Billing:This is one of the prime areas in which business process management in healthcare can make a huge difference. With complete automation of this critical area of business, healthcare units ensure that there is total coordination and traceability of the billing process.

Software:Apart from billing, another area in which business process management in healthcare helps tremendously is software. Software applications can bring about a huge change in the speed of operations. This area of BPM in healthcare reduces the need for human intervention at various stages of the business process.

Big data:Another of the areas in which business process management in healthcare holds huge promise is big data. Big data can help to make sense of various data used in healthcare administration and disease management across entire geographies. This makes the role of business process management in healthcare all the more meaningful and exciting.

 

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The increasing role of the social media in healthcare

 

The increasing role of the social media in healthcare 6With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare.

Whatever the identifiable or unidentifiable reasons for the convergence of social media in healthcare; the fact is that social media in healthcare is a major phenomenon that is here to stay.

Social media in healthcare is being analyzed for potentially huge business opportunity, and it is being taken up for serious discussion in legal circles, with the American Congress and many other legislative bodies around the world thinking of taking serious steps for regulating it.

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The most fundamental aspect of social media in healthcare is that its growth has been helped by the core feature it brings: its ease of adaption in this sector. Healthcare information, as we all know, is very vital, and speed is of great importance. This is why social media in healthcare has come to be one of the most talked about scenarios in the healthcare today, propped in no less measure by the gigantic size of the American healthcare economy.

The advantages social media brings into healthcare

 

The increasing role of the social media in healthcare 1As just seen, the social media in healthcare facilitate great use because they help transmit information at a pace that was difficult to imagine till recently. With the development of the electronic health records (EHR) in the US, technology has made possible the customization of health records. A platform like the social media can help accelerate this pace enormously. It can also help practitioners and other stakeholders of healthcare information, such as Business Associates and Covered Entities and a host of related ones gather information and transmit it and process it at lightning speed.

Concerns

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The enormous benefits that the social media bring into healthcare notwithstanding; there is room for serious concern.

Like all other technology-driven tools, the social media in healthcare comes with an inherent risk: the laxity of records. Loose or nil security or healthcare records are a serious cause for concern. The recent breaches in health data have cost many healthcare organizations in the US millions of dollars.

The social media in healthcare give an opportunity for marketers to pitch their products or services, but they also open up lots of opportunity for the unscrupulous among these to exploit and manipulate this information. This is akin to the potential drawbacks credit cards and other such facilities bring. The social media in healthcare is a tool that is open to a high degree of vulnerability to breach. This is all the more true of new technologies, such as the cloud, which the social media in healthcare have embraced with open arms.

So, while the social media in healthcare is a force to reckon with, it is not something that is totally free of drawbacks. Till regulatory action frees the sector of these, the social media in healthcare will continue to grow, albeit with its concerns.

 

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Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an understanding of the government’s outlook and stance in these matters.

There are two aspects of the export, import and trade compliance principle:

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General export, import and trade compliance principles

 

As can be understood from the description of the concept of export, import and trade compliance principle; export, import and trade compliance principles laid out by the government and requiring compliance with their guidelines are fixed. Organizations cannot manipulate or tamper them. Doing so, naturally, invites penalties.

However, the export, import and trade compliance principles set out by individual companies are conditioned by their own ethics and culture. These are a reflection of how organizations carry out their export, import and trade compliance principle, something that they themselves have laid out.

export-import-and-trade-compliance-principleAdapting the right export, import and trade compliance principle and implementing it is a reflection of how well the organization understands the business and the market and how well it is able to maintain its integrity among its circles. Needless to say, an organization that says one thing and does another is seen in a negative light by its peers.

 

Organizations specialize in helping to implement export, import and trade compliance principle

 

Just as there are many organizations which are in the business of ensuring many complex fields such as governance, risk and compliance (GRC) and technology compliance; several organizations specialize in helping organizations implement both the export, import and trade compliance principle as laid out by the government, and their own export, import and trade compliance principles.

export-import-and-trade-compliance-principleWhether an organization gets its export, import and trade compliance principle implemented through an outside, third party or does it on its own; there is no escaping the fact that export, import and trade compliance principle is something that is mandatory to state and implement accordingly.

Overlaps and alignments of organizational, governmental and trade bloc requirements

export-import-and-trade-compliance-principleEven when organizations draw up their own export, import and trade compliance principle; they are bound to include the latest and relevant regulations, policies and procedures as laid out by the government. Many internal export, import and trade compliance principles and external (those prescribed and required by the government) overlap on many occasions with those of trade blocs such as the North American Free Trade Agreement (NAFTA), European Union Preferential Trade Agreement, Association of Southeast Asian Nations (ASEAN), Mercosur, etc. Export, import and trade compliance principles from these different sources should align with each other.

Reasons for export, import and trade compliance principle implementation

 

The export, import and trade compliance principles laid out by respective governments are in place because of many important reasons.

 

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