Growth and Forecasting for next Upcoming Year Until 2025

Artificial Intelligence in Diabetes Management Market 2019 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. The Market report offers noteworthy data regarding industry’s growth parameters, the current state of the market in terms of analysis of possible economic situations and macroeconomic analysis. This report features competitive scenarios from the recent technology and provides a comprehensive analysis of key growth strategies adopted by key players.

The report has been accumulated through meticulous primary and secondary research, which encompasses interviews, inspections, and observations of experienced analysts, as well as proven paid sources, news articles, annual reports, trade journals, and company body databases. The study also presents a qualitative and quantitative evaluation by analyzing the data collected from industry professionals and market participants across crucial factors in the industry’s value chain. These segments are studied in detail for the market estimates and forecasts at regional and country level.

This report focuses on the Artificial Intelligence in Diabetes Management Market outlook, future outlook, growth opportunities and core and core contacts. The purpose of the study is to present market developments in the US, Europe and other countries. It also analyzes industrial development trends and marketing channels. Industry analysis was conducted to investigate the impact of various factors and to understand the overall appeal of the industry.

Reasons for buying this report:

• It offers an analysis of changing competitive scenario.
• For making informed decisions in the businesses, it offers analytical data with strategic planning methodologies.
• It offers a seven-year assessment of the Global Artificial Intelligence in Diabetes Management Market.
• It helps in understanding the major key product segments.
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• It offers a regional analysis of the Global Artificial Intelligence in Diabetes Management Market along with the business profiles of several stakeholders.
• It offers massive data about trending factors that will influence the progress of the Global Artificial Intelligence in Diabetes Management Market.

A detailed outline of the Global Artificial Intelligence in Diabetes Management Market includes a comprehensive analysis of different verticals of businesses. North America, Latin America, Asia-Pacific, Africa, and Europe have been considered for the studies on the basis of several terminologies.

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Cracking the Code to Healthcare Billing, Coding and Reimbursement

Medical billing, coding, and reimbursement are the triumvirate that constitute the heart of a healthcare financial system. These three systems work in tandem with each other; yet, one miss in the cog in the wheel results in utter chaos. The whole system can go into disarray.

A marathon, four-hour session that is being organized on October 17 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will explain all these elements in detail, so that confusions regarding the same can be eliminated.

At this session, which meets AAPC guidelines for 6.0 Core A continuing education units, Rich Hendriksen, Chief Executive Officer and founder of Nokomis Health, will be the expert. Kindly log on to https://www.globalcompliancepanel.com/virtual-seminar/4-hour-virtual-seminar-on-medical-claims-boot-camp—cracking-the-code-to-healthcare-billing,-coding-and-reimbursement-10309LIVE to register for this valuable session.

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At this course, the expert will explain the fundamentals of medical billing, coding, and reimbursement. He will show how all of these components work with each other. He will demonstrate how to practically apply all the latest industry knowledge and standards. As a result of this learning, those who work with medical claims and claims data stay ahead of the game. They will learn the following:

• The claim flow process from registration through adjudication and payment
• How physicians and hospitals set and manage charges
• Critical data elements on the two major claim forms and what they mean
• How and why the major coding systems are utilized
• How various reimbursement methods are used by payors.

The expert will organize the learning in this session into three parts: the life cycle of a claim, coding systems, and reimbursement. He will explain each of these in depth.

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About the expert: Rich has 30 years of experience in healthcare systems, coding, billing, and reimbursement. He has led managed care departments and provider contracting units at a variety of organizations, including hospitals, clinics, and health plans.

Rich has worked with over 70 different organizations, ranging from hospitals and clinics to third-party administrators, law firms, and internet-based companies. As a respected industry expert, he is well known for his unparalleled depth of knowledge in all aspects of healthcare coding, billing and reimbursement.

Medical Device Recalls: How to Properly, Compliantly and Promptly Deal with a Recall

The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical devices, under certain circumstances (e.g., situations involving serious and immediate hazards to health) and controls.  With very few exceptions, device recalls by companies are voluntary.

There are three regulations promulgated by FDA that define their authority and the requirements applicable to device manufacturers and importers for the correction or removal-collectively known as recall-of medical devices; the requirements for these regulations are outlined in 21 CFR §7, 21 CFR §806, and 21 CFR §810. Each of these regulations is presented in detail in the following pages. Compliance with these three regulations also touches upon other regulations administered by FDA.

Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years.  We will take the time to interact though the day to navigate all aspect of the recall process

This course will provide understanding recall compliance and the interrelationship on Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.

Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance.  Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.

Areas covered by the Instructor:

Determine what actions are taken in a medical device recall

• Cite the regulatory requirements for recalls/ field actions regarding medical devices
• Reference and use medical device recall authority and guidance documents
• Identify and understand the applicable regulatory standards and guidance documents
• Identify the different recall types and classifications
• Explain what types of communications are required
• Define what effectiveness checks are
• Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall
• Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
• Firms MDR reporting and FDA’s handling of MDR reports
• Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
• Minimize your risk of regulatory enforcement actions
• Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
• Walk-through of case examples
• Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.

Why should you attend : Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

Areas Covered in the Session

• Applicable and relevant regulations in EU, Canada and US
• Definitions
• Medical device adverse event reporting requirements in EU, Canada and US.
• Medical device vigilance system during the post-production phase in EU.
• Mandatory medical device problem reporting requirements in Canada.
• Mandatory medical device reporting requirements in US.
• Review of actual reporting forms in EU, Canada and US
• Applicable and relevant guidance documents
• Conclusion

Who Will Benefit:

• Regulatory Affairs Managers, Directors and VPs
• Clinical Affairs Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Compliance Managers and Directors
• Sales and Marketing Managers, Directors, and VPs
• Complaint Handling and Risk Management Managers and Directors
• Site Managers, Directors, and Consultants
• Senior and Executive Management
• Compliance Officers and Legal Counsel
• Business Development Managers, Directors, and VPs

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200+ followers. WOWWWWWW…

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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Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices

Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality.

The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”.

FDA’s complaint handling guidelines are critical for ensuring that an organization maintains safety with regard to the medical devices they manufacture. Errors in medical devices can result in complaints, and improper handling of complaints can lead to problems for the patient, ranging from injury to fatality.

It is to prevent these problems that the FDA has issued complaint handling guidelines. FDA’s thinking is based on the reasoning that a complaint may be an indicator of serious safety, but implementing effective complaint handling guidelines can greatly mollify the gravity of the issue. It is also the first step to initiating new product development, which in turn has the potential to greatly reduce risks associated with noncompliance.

Regulations in place

Provisions relating to effective complaint handling provisions are contained in FDA 21 CFR Part 820 and GxP regulations.

Firstly, these complaint handling guidelines require medical device manufacturers to maintain complaint files. Manufacturers have to make this the first step towards establishing a sustainable complaint management system.

Secondly, Section 198 of Part 820 warrants the following:

Thirdly, FDA 21 CFR Part 820 requires the manufacturer to establish and maintain procedures for the receipt, review, and evaluation of complaints.

What should records of investigation contain?

Records of investigation should contain the following:

• Identifiers related to the device and reported event
• If Medical Device Reporting is made, it should investigate the following:
  • Whether there were any specifications the device failed to meet
  • Whether it was for treatment or for diagnosis that the device was being used
  • In what way the device was related to the reported event, if applicable

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Design Control for Medical Devices

Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have to take to ensure that:

1. The medical device being manufactured is safe
2. The medical device manufacturer follows all the steps and procedures for ensuring that the device it develops is what was meant to be developed
3. Design controls for medical devices have to be put in place to ensure that the final product – the medical device – meets all the required and prescribed regulatory procedures and guidelines and meets the customer’s expectation

In short and simple terms, design controls for medical devices are verifiable and provable assurances that medical device manufacturers have taken adequate steps to guarantee that a medical device meets its set of required standards and procedures to ensure its safety and meet customer requirements.

FDA and ISO expectations of design controls for medical devicesBoth the FDA and the ISO have regulatory requirements from medical devices that expect some Design Control standards. The FDA’s requirements for design controls for medical devices are spelt out in FDA 21 CFR 820.30, while ISO 13485 is the standard for design controls for medical devices. Although formed by different regulatory or standards bodies; both the FDA 21 CFR 820.30 and the ISO 13485 are essentially similar. Their purview of the areas of design controls for medical devices is almost identically similar to each other. Sections of the FDA 21 CFR 820.30 and the ISO 13485 speak of requirements relating to the following in their various sections:

• Design and development planning
• Design output
• Design input
• Design review
• Design verification and validation
• Design transfer
• Design changes.

In just one area of design controls for medical devices, namely Design History File, there is a small difference, in that while the FDA’s regulatory requirements for design controls for medical devices include DHF; in the case of the ISO 13485, this is treated separately.

There is thus near total convergence between the FDA 21 CFR 820.30 and the ISO 13485 when it comes to design controls for medical devices.

Basic requirements of FDA 21 CFR 820.30 and ISO 13485Both the FDA 21 CFR 820.30 and the ISO 13485 have expectations for design controls for medical devices. These are the core areas:

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The Investigational New Drug Applications mechanism in the USA

The IND is a process which gives the sponsor the opportunity to start marketing across the States of the US without having to complete the formal process. it also gives the patient the assurance that the drug that is being administered may not have gone through the full regulatory process as yet, but is as effective as one that is already in the market. The FDA has three mechanisms in place for submission of an IND.

Present Federal law requires a manufacturer who wants to market a drug in the US to subject the drug to an approved marketing application before it gets transported and/or distributed for interstate commerce, i.e., within the different States in the US.

Since it is very likely that the sponsor of a clinical trial may want to ship the investigational drug to clinical investigators across several states, it is but natural that the sponsor would look for exemption from this legal requirement. The Investigational New Drug (IND) Applications in the USA is the mechanism through which this exemption issues from the FDA to the sponsor.

We can understand the Investigational New Drug Application this way: it is a request made by the sponsor of a clinical study with the FDA asking for its authorization to administer a biological product or an investigational drug to humans before the product goes through interstate shipment. The IND application should also be made before administering a drug that is not the same as an approved New Drug Application or Biologics/Product License Application.

The rationale behind filing Investigational New Drug Application

 

Ensuring a drug’s safety for use in humans is the basis for the entire idea of filing an Investigational New Drug Application. This is the prelude to the steps for its commercialization. By paving the way for further actions such as data collection; the Investigational New Drug Application is often the predecessor step for reinforcing the drug’s safety. An Investigational New Drug Application can be understood or taken as some kind of assurance or guarantee that when the drug that is at this stage of studies is administered on humans; it is not harmful and does not carry risks.

Ensuring a drug’s safety for use in humans is the basis for the entire idea of filing an Investigational New Drug Application. This is the prelude to the steps for its commercialization. By paving the way for further actions such as data collection; the Investigational New Drug Application is often the predecessor step for reinforcing the drug’s safety. An Investigational New Drug Application can be understood or taken as some kind of assurance or guarantee that when the drug that is at this stage of studies is administered on humans; it is not harmful and does not carry risks.

The FDA’s roleThe FDA’s comes into the picture when the sponsor who files an Investigational New Drug Application wants to test the effect on humans of molecules that it has screened and identified. At this stage, the status of the molecule changes into a new drug that is subject to the requirements set out by the regulatory system.

Kinds of INDsThere are three types of Investigational New Drug Applications:

Elements of an Investigational New Drug Application
The FDA requires an Investigational New Drug Application to contain the following:

• Studies carried out for testing animal pharmacology and toxicology
• Information about the manufacturing aspects of the drug
• Information about the clinical protocols and investigator of the Investigational New Drug Application

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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:

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.

Adapting 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.

Whether 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

Even 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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Murj wants to give data collection from implantable medical devices an upgrade

Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.

The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd Butka began thinking about ways to make the data collected by cardiac technologies more easily available to physicians and diagnosticians.

Now the company is coming to market with backing from True Ventures and Social Capital.

Unlike existing technologies that deliver data in static .pdf documents, Murj collects the data and stores it in its own off-premise data warehouses. Using dashboards and other visualization tools doctors can get a better read on what’s going on with their patients’ heart health, Butka claims.

“The information comes from the devices to the implantable devices’ servers… We ping the servers,” Butka explained.

The Murj launch wraps up three years of work developing the technology, which was founded in 2014 and raised its first money in 2015.

The company, based in Santa Cruz, brought on Chris Irving as its lead designer and Patrick Beaulieu, an 18 year veteran of the medical device business, as its chief technical officer.

I think of the company as sort of an Apple Healthkit for implantable devices. If it can expand its scope beyond pacemakers and heart monitors to a broader range of implantables, it could be a pretty big business.

As the population ages, and technologies improve, demand for more persistent diagnostic tools will grow.

In a sense this is part of a number of companies that are trying to provide better tools to manage the data coming off of the sensors that we’ve got all around us.

 

Read More: http://snip.ly/kvqol#https://techcrunch.com/2017/04/18/murj-wants-to-give-data-collection-from-wearable-devices-an-upgrade/