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Foreign firms that manufacture medical devices and/or products that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products into the U.S., the product must meet FDA regulatory requirements. FDA does not recognize regulatory approvals from other countries. These requirements include registration of establishment, listing of devices, manufacturi

Transforming a product-driven firm to a customer-driven enterprise is inevitable in order to stay ahead in today’s extremely competitive markets. The days of mass marketing, mass media communications, and little-to-none direct interface with customers are long gone. The emphasis, now, should be on maximizing customer relationships and becoming customer-driven organizations rather than merely selling products. The technological advancements of this age offer potent tools for organizations to util

The last couple of weeks I have been pointing out some of the failings of the Three Lines of Defence (3LoD) Model of Risk Management. The red tape it creates and the outsourcing of responsibility for managing risk.

However, there is something even worse about the 3LoD model. It has a fundamental flaw that risk and compliance functions battle with every day. The language that surrounds it creates barriers between the business (first line) and both the risk and compliance functions (second line) an

Almost every business in the country is bound by regulations. There are regulations that govern the way a business can treat its employees, the way it can operate in its environment, and so on. Different industries have varying amounts of regulation. There are industries where regulation is minimal, and businesses are generally not worried about regulatory bodies breathing down their neck. Then there are industries where everything is governed by regulations – where there are so many regulations

Most Transformation initiatives fail to achieve their anticipated objectives.

Change Management is all about engaging and rallying people — at all levels in the organization — to make the transition and sustain that change. It is critical to ensure that the entire workforce is eager and ready to embrace the required new behaviors. More often than not, the technical side of a change initiative is well planned, but it’s the implementation part that fails — particularly, changing the mindsets and be

The global high-end synthetic suede market is segmented into four major applications, namely automotive, fashion, furniture, and others. These applications are further sub-segmented based on their use of high-end synthetic suede. The global high-end synthetic suede market is growing at a rapid pace, owing to its enhanced functionality and properties compared to that of leather.

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Another factor leading to increased adopt

Real Estate (Regulation and Development) Act 2016 aims to protect home-buyers and boost investments in the real estate sector. Under this Act, each state is entitled to have a RERA authoritative body that oversees and regulates the real estate sector in that specific state. One of the primary objectives of the organisation is to initiate quick resolutions of disputes related to the real estate sector.

Against the backdrop of a growing economy, Maharashtra continues to hold a considerable share in

The smart shoes market has surfaced with the integration of sports sensors and development of sports gadgets. Soft sensor networks are circuits made out of flexible sensors that are in-built into shoes, which further helps to measure the biomechanical data. The information gathered provides individual to keep a track of their movement and, in the best way, it prevents injuries. For example, Stridalyzer is an insole detecting the force and pressure, which also helps in injury prevention.

What are

Boris: Hello ladies and gentlemen! Welcome to our live discussion about innovation in insurance. Today we have our interview with Peter Stockhammer.

Peter is Managing director at Generali Vitality which is the holistic health and wellness-based insurance programme that captures the global trend of healthy living.

Peter thank you for meeting with us today. Can you tell me a short story about Generali Vitality?

Peter: Yes, it’s a pleasure to be here. Currently, at Generali Vitality, we are mov

The growth in the automotive sector and rising governmental concerns toward greenhouse gas emissions, have led to the increased demand for rechargeable batteries in the country. LG Chem, Samsung SDI, and SK Innovation are among the leading South Korean battery manufacturers that have planned for a combined investment of XX trillion Won by 2020. They have also announced the break-up of this investment, wherein one fifth would go to the R&D, and the remaining would be utilized for the expansion of

Content Services is an emerging method to logically and efficiently capture the information, which is further delivered to the right department or the process of using digital channels (typically through the cloud). Content Services is based in the cloud, therefore, it ensures that the businesses are addressing the changing the compliance requirements along with remaining cost-effective and scalable. Content services are a set of services and micro services that are personified either as a combi

Insurance Nexus is delighted to announce we are bringing together key figures from OneBeacon, Canada Life and AITE Group to give you the strategies to understand your customers agenda and move towards a truly connected model. http://bit.ly/2LiQeJF

Insurance customer expectations have increased dramatically, and carriers must become truly customer-centric in order to meet those expectations Building a connected carrier isn’t easy but it is now the bare minimum to ensure survival in this fiercely c

Payment processing solutions market is highly vast and dynamic, as the developing countries focus on innovation and research & development. The developing countries are early adopters of technologies in different verticals. Out of various modes of payment, a credit card is the best mode of payment by consumers in both ways online and point-of-sale (POS) methods worldwide.

What are payment processing solutions?

Payment Processing Solutions can be defined as the process and service that mechanizes p

The global food economy is being progressively compelled by the gradual change in the food consumption patterns. Indoor farming is a perfect alternative to conventional farming, which has been adopted since early 1900s, but at non-commercial and small scales. The practice of growing crops in greenhouses, which have been predominantly low-tech, has been in existence since a long time. With the innovations in urban planning and sustainability, indoor farming has gained importance as a local method

Last week I pointed out that one of the failings of the Three Lines of Defence (3LoD) risk management model was that it created a whole lot of red tape as regulators looked for evidence of each line delivering on its promises.

Another problem is that the implementation of the 3LoD model in many organisations has resulted in the outsourcing of responsibility for managing risk from the business to the risk and compliance functions. Much the same way as organisations did with safety, environmental,

The police in Port St. Lucie Florida have claimed that scammers are now posting homes as available for rent or purchase. You rent/purchase the home by putting a deposit down on the house, but you’re never given any keys.

The scammers are getting their victims to the property and even a tour of the house, but when it comes time to move in, the victim is left without any options. The tour aspect of the scam is important here. This legitimizes the fake agent as real.

Local realtors say that there are

The Liquid Detergent packaging has undergone significant format and design transformation over the years owing to product development to meet consumer expectations and lifestyle changes. According to industry research, the penetration of washing machines in the estimated household has increased significantly and is optimistically estimated to rise over the upcoming years. This ongoing change in housing conditions and lifestyle has compelled detergent manufacturers to come up with new and innovat

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Gain actionable data intelligence to increase the legal department's value-added For the legal department of an organization, compliance is the name of the game. Almost every action taken within the entity management ecosystem is to ensure that proper procedures are followed so that all rules and regulations are followed in accordance to the law. Manually tracking entity data has proven to create more complications than solutions it provides. As your

Recently, a man was accused of pretending to be a real estate agent just to steal some jewelry from an open house. According to Toronto police, he has been arrested.

The victims are a couple (their identity isn’t being listed for their safety). They had an open house in a small city called Oakville. It’s in Ontario, which is about an hour west of Toronto (also in Canada). According to the investigators, a 29-year-old man saw an online ad for the open house. He decided to pretend that he was a rea