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4 Essential Steps to Eliminate Database Drama
Back in the day when I was still apart of corporate America, I found myself tasked with the huge job of figuring out what spiffy new company wide software system we needed and what would work best for us.Which computer system would work best? How do I know? Hour after hour of boring computer system presentation, endless trade shows and phone calls and I still didn't have an answer. By the time you figured everything in, each system I looked at was priced somewhere around $170,000.00.With $170,000.00 on the line, you can imagine I was not about to make a snap decision. So I changed my approach a bit. I really dived into why the old software wasn't working and what the team really wanted the system to do.What kind of difference could finding out what the team wanted make? Well, it turns out that 85% of the system we had was fine. But because I was able to nail down the processes behind what we needed, I hired a programmer at $25.00 per hour to come in and make the upgrades. The whole project cost about $2500.00 NOT $170,000.00.You're probably not sitting around thinking about spending $170,000.00 on new software, but you, like many of my clients may be scratching your head wondering if you should buy that new database or new software program that your friend has been raving about.Your pal maybe raving about a software packages like Outlook, ACT!, Goldmine, Filemaker Pro, or Access, which are all excellent programs. BUT, (there's always a big but) in order for them to be effective for YOU, you need to figure out what you need them to do for you.Here's what I mean. Think of a blank piece of paper. That paper could be anything. A love letter, a list, a piece of stationary, you could fold it and make it a card, you could crun

. Regardless of the intended global harmonization, participating countries are preserving their national cultures and languages by requiring product information in their own local languages.

IVDD, MDD & AIMD…more languages!
Depending on device classification, to legally display the CE mark, the IVDD, MDD, and AIMD all mandate that manufacturers provide all labeling, information for usage, documentation, and marketing materials in the official language(s) of the end-user's Member State, taking into account the training and knowledge of the potential users as stated in Article 4, Paragraph 4, IVDD 98/79/EC .

Changing Careers - an Inevitable Step
When you get your first job, thinking about different careers is probably the last thing on your mind and fifty years ago, most people entering the workforce would expect to remain with the same employer until the end of their working life. However, the situation has changed radically in recent years and so we all need to know how to manage career transitions if we are to get the best out of our careers. Your ability to deal with change will be partly determined by how well you plan in advance. Of course, your interests and priorities will change at different stages of your life, which can make forward planning a little complicated. It is important to step back from everyday reality for a little introspection, which will help you contemplate your current careers options and look at where you might want to be 20 or 30 years from now. Naturally, this is going to expand and develop as you gain experience and take on responsibilities. This article will help you to plan as effectively as possible.To begin with, you need to be clear about where you are at the moment and why you have made the choices which got you there. This involves being completely honest with yourself - did you choose your present job because it was the first one you were offered, or it's in the field your parents or teachers felt you should enter? And what were your intentions when you started this job? Did you plan to be there just until something you really wanted, but after 10 years that still hasn't happened? Or did you plan to climb the ladder within the firm, but find you haven't got any further than the first or second rung?Next you need to consider how your ambitions and priorities have changed since leaving college. Do you have completely different aspirations now that you ha

Sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the European market's substantial global market share. Estimated at 30% of the global medical device market, the European community poses increasing regulatory challenges for medical device manufacturers. Regulations controlling the manufacturing, marketing and usage of medical devices in the EU are forcing manufacturers to incorporate language translation and localization into global development strategies as individual Member States demand product information in the language of the local user.

An exigent regulatory hurdle facing the medical device industry is the European Union's IVDD 98/79/EC directive which went into effect December 7, 2003. Formulated five years ago, the IVDD 98/79/EC dictates that as of the December date, all new in vitro medical devices must bear CE Marks or face refusal into the European market or regulatory, criminal or product/civil liability.

What is the guiding principle behind the new directive?

The IVDD Directive virtually eliminates the costly regulations imposed by individual member states. Manufacturers who comply with the Directive will be able to apply the CE mark to their products and market them freely within member states of the EU. The IVDD (In Vitro Diagnostic Devices Directive) is one of three associated directives issued by the European Union, which together cover all forms of medical equipment with the intent to ensure that only safe and effective products are sold in the European market. The directives clearly outline regulations regarding manufacturing, importing, and marketing of such devices. The IVDD specifically involves in vitro ( in an artificial environment outside the living organism ) medical devices that examine human fluids or tissue samples to identify, diagnose, and monitor medical conditions. The IVDD 98/79/EC brings in vitro devices in line with other medical devices already regulated by the EU, the MDD (Medical Devices Directive) and the AIMDD (Active Implantable Medical Devices Directive).

The IVDD and it sibling directives apply progressive regulatory requirements to medical devices and their accessories depending on the classified risk they present to the user, defined in the directive as Class I through III. Unless the classified product is a low-risk Class I device that does not contain any sterile packaging or a measuring function, manufacturers require a third-party Notified Body to independently certify the device's compliance to the Directive's Essential Requirements (a.k.a. Annex I)-good faith is not enough. Additionally, in a new twist within the Directive, the authorized representative shown on the device label for Class I devices manufactured outside the EU may be required to produce the technical file, including copies of all translated materials. Any incorrect labeling or instructions for use may lead to regulatory criminal or product/civil liability in the EU.

Any medical device manufacturer wishing to market its products in the European Union is fully responsible for complying with the corresponding safety and administrative Essential Requirements and must display the CE mark of conformity as stated in Article 16 of the IVDD 98/79/EC . If that's not a red flag, consider the next regulatory deadline facing in vitro device manufacturers: By December 7, 2005, the European Union will not only require a CE mark to legally market a product, but will require a CE mark to legally put a medical device into service—a requirement much more critical to the revenue of manufacturers and healthcare!

CE Mark: A passport to the European Union
An abbreviation of a French phase "Conformite Europeene," the CE mark indicates that the medical device manufacturer has conformed to all the obligations set forth by the Directive 98/79/EC of the European Parliament. Affixing this multinational standardized mark to a product will allow any global manufacturer a "passport" to freely distribute their products within the European Union without additional quality testing or approvals. Reflective of the 1946 Treaty of Rome, the CE mark is a conformity tool that is intended to further promote the establishment of a single market where the free movement of goods, persons, services and capital are ensured. Fundamentally, the CE mark and the medical device directives remove many regulatory hurdles while providing stronger regulations for smaller countries; however, it also creates critical language compliance issues that may prove to be costly for manufacturers. Regardless of the intended global harmonization, participating countries are preserving their national cultures and languages by requiring product information in their own local languages.

ATM Business Success is Just Like Real Estate – Location, Location, Location!
Most people don’t realize that most ATM machines are not actually owned by banks. If fact most of the ATMs you see at bars, gas stations and many other high traffic locations are operated by the business owners or even individuals like you or me. You need not be affiliated with any back to own and operate ATM machines and once you have a few basics down, you can create a sizable passive income simply by placing and replenishing ATM machines. In this article I’ll tell you what you need to know to get started.The first thing you need to consider when starting an ATM business is whether to rent or own. It’s almost always better to rent machines than to buy them outright. If you rent the machine, you will be paying a chunk of your proceeds each and every month for the rental of the machine, but if the machine breaks, the rental company is responsible for fixing it. Unless you know how to service ATMs yourself, this is a huge advantage. Repairing an ATM can be expensive, as it requires special diagnostic tools that are not readily available to the average person.The next thing you need to think about is where to place the machine. The ideal place for an ATM is in a high-traffic location with a lot of foot traffic. A location where customers are required to pay cash by the stores or vendors is perfect. A local fair or other gathering with many vendors is a good example of this kind of ideal location. It’s also effective to place an ATM in a location where it’s just easier to pay in cash. For example, a busy bar will see high ATM usage because it’s just easier to pay in cash than run a credit card for every drink purchased.Next, you’ll need to be sure to keep the machine stocked. An ATM without money can’t make you money, so you should

member states. Manufacturers who comply with the Directive will be able to apply the CE mark to their products and market them freely within member states of the EU. The IVDD (In Vitro Diagnostic Devices Directive) is one of three associated directives issued by the European Union, which together cover all forms of medical equipment with the intent to ensure that only safe and effective products are sold in the European market. The directives clearly outline regulations regarding manufacturing, importing, and marketing of such devices. The IVDD specifically involves in vitro ( in an artificial environment outside the living organism ) medical devices that examine human fluids or tissue samples to identify, diagnose, and monitor medical conditions. The IVDD 98/79/EC brings in vitro devices in line with other medical devices already regulated by the EU, the MDD (Medical Devices Directive) and the AIMDD (Active Implantable Medical Devices Directive).

Grab Customers' Attention With Advertising Balloons
Let's face it: most small- and medium-sized companies don't have huge advertising budgets. Traditional media, such as print, television, and radio advertising are far too expensive. And, for those businesses that rely on walk-in traffic, Internet advertising won't reach the intended audience. Thankfully, there's another advertising medium that's incredibly effective for a variety of businesses: advertising balloons. Advertising balloons - also known as advertising blimps and advertising inflatables - are an incredibly cost-effective method of gaining the attention of passersby and turning prospects into customers. Starting at slightly over $100, the cost of an advertising balloon can be recouped in no time at all. There are several different types of advertising inflatables. Advertising blimps have the traditional blimp shape, but come in a variety of sizes. They are easily customizable with a company logo, special message, or unique combinations of colors. Advertising blimps can be large enough to attract attention from miles away, or small enough to catch the eye of a trade show attendee. Larger advertising blimps can even be lit at night to garner notice 24 hours a day. Round advertising balloons are also attention-grabbers. Again, they come in all sizes and can be flown high above the ground, acting as traffic magnets for a business' location. A business can also buy a pre-made advertising inflatable, such as one in the shape of a hot air balloon that says, "Grand Opening." Eye-catching shapes and colors are sure to attract customers. Similarly, dancing balloons (also called wind dancers) are eye-catching. Inflated with a cold air blower, dancers will delight both adults and children. However, they're generally ma

directive as Class I through III. Unless the classified product is a low-risk Class I device that does not contain any sterile packaging or a measuring function, manufacturers require a third-party Notified Body to independently certify the device's compliance to the Directive's Essential Requirements (a.k.a. Annex I)-good faith is not enough. Additionally, in a new twist within the Directive, the authorized representative shown on the device label for Class I devices manufactured outside the EU may be required to produce the technical file, including copies of all translated materials. Any incorrect labeling or instructions for use may lead to regulatory criminal or product/civil liability in the EU.

Which Incorporation Services You Need And Which You Can Do Without
If you’re reading this post, you’ve probably decided two things:1. Hiring an attorney to form your LLC (at $1,500 - $3,500) is too expensive; and2. You’re not going to do it yourself--filling out government forms gives you hives.The only option left is to choose an online incorporation company to form your LLC for you.The only problem is that there are hundreds of online incorporation companies ready to sell you a dizzying array of services and a confusing pricing structure.Which services do you need?Probably the biggest factor in determining the cost of forming an LLC are all the add-ons offered. In the marketing world these are called “upsells”. Understand that your plain-vanilla LLC formation is relatively simple. The company pays someone (or more likely has software auto-populate the form) to fill out an Articles of Organization form from the state where you’re forming your LLC. Then they mail that form with a check to the Secretary of State. Some time later, usually a few days or weeks at most, you have a legal LLC. There’s only so much that a company can charge for simple paper-shuffling of that kind.So the real profit for online incorporation companies are the add-ons. I’m not begrudging them that—everyone needs to make a profit. The only question is which services do you really need, and which can you live without.Essential Services1. Registered agent service if you incorporated in a different state than you live in.This one is clear cut. If you don’t have a physical address in the state you’re forming your LLC in, then you don’t have a legal LLC. Example: if you form a Nevada LLC, then you need to live or have your business in Nevada with a physical address for the govern

a CE mark to legally market a product, but will require a CE mark to legally put a medical device into service—a requirement much more critical to the revenue of manufacturers and healthcare!

Getting Ahead at Work Part II
Here are five ways prove your worth and get ahead at work from "The Office Coach:"Be Proactive This is the number one problem of new workers in the workplace. They spent their entire career up to this point in schools where they were spoon fed assignments and activities. They were always told where to go and what to do and now, suddenly, they’re at a job and they don’t know that they are required to think for themselves. Believe it or not, I’ve noticed it in some older workers too. We live in a different world now than, say, 20 years ago. This is a world of mergers, downsizing, technology that runs at the speed of thought. If you aren’t in on it, you risk being left behind. One way to be in on it is to develop an innovative mind. Learn a process first, then see how you can improve it. Strive to understand more than just your job so that you can see how what you do affects others. Find new ways to make your boss’s job easier and to make them look good. Do this, and you may find another partner on your path to success. Be Confident I learned early on, that if you walk into someone’s office, look them in the eye and tell them what you want and why, that more often than not, you’ll get it. Confidence is a position of power and it doesn’t require that you always know every detail of what you are doing. Women are especially susceptible to this because many men are taught early on to stand up straight and look someone in the eye. Many women, on the other hand, are cultivated to be more submissive in their approach, more helpful. Now, I know this is a sweeping generalization, so please don’t crucify me for it, but this is hundreds of years of human nature and I’m not sure how long it will take for women, as a whole, to completely

. Regardless of the intended global harmonization, participating countries are preserving their national cultures and languages by requiring product information in their own local languages.

Documentation Translation Requirements — Conformity Assessment Procedures Manufacturers are required to translate the documentation relating to the production, testing and quality processes in the official language(s) of the Member State in which the procedures are carried out as stated in Article 9, Paragraph 11 of the IVDD 98/79/EC. Depending on device classification, these documents must include a number of required disclosures dependent on the product classification. Depending on marketing and distribution objectives, some products may require up to 12 languages, creating complicated multilingual product labeling and IFU challenges. There can be over 20 information pieces required for each product label of IFU, depending on the classification as detailed in Annex I, Part B, Section 8 of the Directive.

Table I Official Language(s) of EU Member States

Member State Official language(s)

Austria - German

Belgium - Dutch, French & German

Denmark - Danish

Finland - Finnish

France - French

Germany - German

Greece - Greek

Ireland - English

Italy - Italian

Luxembourg - French, German, Luxembourgish

Netherlands - Dutch

Portugal - Portuguese

Spain - Spanish

Sweden - Swedish

United Kingdom - English

Table II
Official Language(s) of EFTA Member States
Member State Official language(s)

Iceland - Icelandic

Liechtenstein - German

Norway - Norwegian

Switzerland - German, French & Italian

( Switzerland is not a EFTA member but requires translation)

Table III
Official Language(s) of Member States Applying For EU Membership
Member State Official language(s)

Bulgaria - Bulgarian

Cyprus - Greek

Czech Republic - Czech

Estonia - Estonian

Hungary - Hungarian

Latvia - Latvian

Lithuania - Lithuanian

Malta - English & Maltese

Poland - Polish

Romania - Romanian

Slovakia - Slovak

Slovenia - Slovenian

Turkey - Turkish

EU Member State Official Languages
Depending on the extent of the product's presence in the European Union, there are currently up to 12 languages required for the labeling, IFUs, documentation, and marketing materials in accordance with the IVDD and MDD necessary for CE mark as displayed in TABLE I .

As the EU continues to grow and the trading barriers dissolve, prospective Member States are actively transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.

In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slovakia, and Turkey, see

TABLE III .
Global Harmonization and International Quality Standards In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulations. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe.

ISO (International Organization for Standardization) Adding to the pressure the current ISO 9000:1994 standard is transitioning to a new ISO: 9000:2000 series effective December 14th of this year. However, as of May 15, 2003, only 19.5% of the total ISO registered North American companies had completed their registration process. This is essential in the entire chain of requirements. The new standard is a consolidation of ISO 9001 and 9002, and has more of a customer satisfaction and continuous improvement focus not present in previous versions.

GMP (Good Manufacturing Practices)
In December 1978, the FDA Good Manufacturing Practices (GMP) Regulation became effective, establishing Quality System Requirements for products regulated under the FDA, including medical devices. In 1990, the Safe Medical Devices Act (SMDA) expand

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Now is the time to launch that new product in the market together with the new face of your business. And what better way to do it than to give out brochures? Brochures are fun, colorful and eye-catching.

Sometimes in business we are so involved in the little things that we forget to refer back to the top of the pyramid. At the top of this pyramid is your company's brand. This is a reminder as to how important your brand is and how properly executing it illustrates its true essence.

Congratulations, you've been promoted. Now what? New leaders often do not realize the extent of the change and the skills required to be a success. Learn to be a super not blooper leader.

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