A New Focus on Information Security

A New Focus on Information Security

According to the FCC, American small businesses lose billions to cyber attacks annually, and 74 percent of small and medium businesses reported being affected by cyber attacks in the past 12 months. The average cost of these attacks for business, per incident, was $188,242. The most important step your company can take is securing your data. This is not only a good idea financially, but also from a legal and regulatory standpoint.

No information system is without vulnerabilities. Hackers, terrorists, viruses, spam, fraud, data theft, system failures, power outages and more can have a significant impact on an organization’s profitability and sustainability. (more…)

Impact of the New 510(k) / PMA Process on Companies for Quality Management

Impact of the New 510(k) / PMA Process on Companies for Quality Management

The entire medical device community is waiting patiently to see how the U.S. Food and Drug Administration changes the 510(k) clearance process. In January 2011, the Agency announced a plan containing 25 actions it intends to implement during the year to improve the most common path to market for medical devices.

According to a press release, the FDA’s key actions include:

  • Streamlining the “de novo” review process for certain innovative, lower-risk medical devices
  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making

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The Impact of SOX on Quality

The Impact of SOX on Quality

Risk is a subject prone to irrationality. We worry about mere possibilities. We ignore probabilities. We focus on perception. We ignore reality. Twenty percent of adults still smoke. Twenty percent of drivers still don’t wear seat belts. Two-thirds of the population is overweight/obese.

Risk is everywhere: market risks, operational risks, business risks, strategic risks, financial risks, environmental risks, etc. It’s too easy to think, “It’ll never happen to me” and ignore risks. Designing a solid risk management model requires attention to all risk areas. (more…)

Is the FDA Keeping the U.S. from Innovation?

Is the FDA Keeping the U.S. from Innovation?

This past January, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) announced its plan of action for implementation of its 510(k) and science recommendations. Under section 510(k) of the Act, announced in August 2010, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin.  While safety is at the core of this regulation, is it also limiting the possibilities for innovation and delivering products to market? (more…)

Managing Quality, Compliance and Risk in a Global Economy

Managing Quality, Compliance and Risk in a Global Economy

Time to market is one of the major reasons we look to the global economy. Acquisitions and mergers can take us across international borders to quickly gain the intellectual property we need. International supplier sourcing can get products more quickly to our manufacturing sites and our customers, or broaden our foot print in a country quicker and faster. (more…)

Compliance is Nothing More than Risk in Sheep’s Clothing

Compliance is Nothing More than Risk in Sheep’s Clothing

Regulatory requirements around the world have grown, creating heavy workloads of documentation and the need for process transparency.  In addition to rising compliance concerns, Life Sciences organizations face increased security measures, including HIPAA, FDAA 2007 and more.

Regulatory risk is the possibility of being out of compliance. For many Life Sciences companies, regulations rule your compliance objectives. How you handle it is based on your product, production processes and your level of tolerance for risk. A high tolerance for risk might equate to lower compliance costs, but potentially higher non-compliance penalties.
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An Argument for Continuous Improvement

An Argument for Continuous Improvement

Let’s say your company has been error-free for years. You pass every audit. You achieve all certifications. You have the ideal quality processes in place. Have you then reached a Quality Apex? You can go no higher?

Perhaps your company isn’t that perfect, but you feel that you have quality under control. You catch defects before they leave the plant. You might have an infraction or two from a regulations standpoint but you easily remedy the situation. Are you also in a position where your quality efforts have reached a plateau? (more…)

Medical Device Recalls: Creating a Balance

Medical Device Recalls: Creating a Balance

Right now, there are some 6.6 billion people in the world, and over the next 30 years, it will soar to over 9 billion. At the same time, the global population is aging, and mostly so in the U.S. and Europe. As the population ages, health care needs will likely increase, leading to an increase in medical device consumption, an industry currently valued at $290 billion dollars. (Kalorama Information, A division of MarketingResearch.com). The U.S. represents the largest medical device market with $130 billion dollars in revenues. (more…)

ISO 9001 – It’s All About Continuous Improvement

ISO 9001 – It’s All About Continuous Improvement

ISO 9001 was created in response to customers who wanted an assurance of quality. The concept was to limit the risk of delivering defective products to customers, with a focus on prevention, detection and correction. ISO 9001 replaced many customer-specific requirements, which suppliers needed to meet in order to make it easier for them to bid for work.

But ISO 9001 should be a quest for improving quality in all operations and not simply getting and keeping a certificate. It should be viewed as a guide for a management system to satisfy its customers and stakeholders with continual success. (more…)

So Now That the Food Safety Bill Has Passed, What’s Next?

So Now That the Food Safety Bill Has Passed, What’s Next?

On January 5, 2011, the Food Safety Modernization Act was passed into law by President Obama.  The new legislation gives the Food and Drug Administration the power to recall tainted food, quarantine geographical areas and access food producers’ records. According to the FDA, the burden of foodborne illness is considerable.  Every year, 1 out of 6 people in the United States — 48 million people — suffers from foodborne illness, more than a hundred thousand are hospitalized, and thousands die. So what does the new legislation mean to food processing companies and manufacturers now? (more…)