Reason for Medical Device Regulatory Compliance Being a Business Decision

The US Food and Drug Administration noticed frequent complaints of a permanent birth control mechanism called Essure. A medical group from Weill Cornell Medicine in New York registered a 10 times higher occurrence of reoperation during the first year of implantation. In Europe, the PIP breast implant remains a permanent scandal. The question here is why are approved devices causing serious safety concerns in the market? Clearly, strict regulatory oversight does not avoid the rise of malfunctioning medical devices. On the device manufacturer side, following the regulations alone does not assure all safety, quality and effectiveness parameters have to be addressed.

Essure, produced by Bayer, was approved via the 510(k) process. This route excludes medical devices from clinical testing if they are proven to be considerably equal to a similarly marketed instrument. As a result, any clinical data achieved from abbreviated studies would be insufficient to give valid and representative conclusions about safety of devices and performance. Should Bayer have conducted a full randomized, blinded clinical investigation instead? The answer to this should be derived from sensible business based decision-making, and not a general one. Completely understanding the features of the product from both profit and risk perspectives is an important keystone of the value proposition for medical devices. The base customers of medical devices are the end-users and/or patients whose requirements should rightfully take higher priority above regulatory rules.

An effective business tool explicit to medical devices that could help to address this is the ISO14971 risk management standard. The requirements of this standard are common for all medical devices irrespective of risk classification and approval methodologies. It requires all device manufacturers to take every valid step to confirm that risk levels are minimized to as low as possible. Vice versa, approval pathways for lower risk devices do not offer relief to risk reduction measures. Therefore, if a complete clinical trial is required to provide a total risk/benefit profile for a device, then this should be done along with the regulatory process. This implies that a risk management process for a 510(k) approval should not be compulsorily less valid than for a PMA.

Any device manufacturer that uses a shortened approval procedure as an excuse to cut risk reduction will not only place a dangerous medical device in the market, but such indifference to basic total quality is in itself harmful to medical device innovation and long-term business competitiveness.

Food Organizations Should Achieve BRC Certification for Food Safety

The BRC Global Standard for Food Safety was developed to specify the safety, quality and operational criteria required to be in place within a manufacturing organization of food to meet its obligations to legal compliance and customer protection. The format and content of the standard is designed to allow an assessment of local, systems and operational procedures of a company by a competent third party – the certification body – with the requirements of the standard.

BRC ISSUE 7 Certification for food safety was published in January 2015, with a continuous focus on management commitment, risk analysis and a critical control point program for Safety of quality management based foods and system support. The aim was to direct the focus of the implementation of good manufacturing practices in the production areas with more emphasis on areas that have traditionally led to recalls and withdrawals.

What is the BRC Global Standard for Food Safety?

The global standard for food safety sets out requirements for the manufacture of processed foods and the preparation of primary products supplied as products to branded retailers, branded food and food or ingredients for use by food service companies, catering companies and food manufacturers. BRC ISSUE 7 Certification will relate only to products that have been manufactured or produced at the place where the check has taken place and will include storage facilities that are under the direct control of the production management of the site.

The BRC Global Standard for Food Safety is a global tool based on the latest safety standards and made food day and methodologies. The requirements of the standard are related to the quality management system and HACCP (Hazard Analysis and Critical Control Point) system, supported by detailed prerequisite programs.

WHY BRC ISSUE 7 Certification is important to any Organization

Most UK retailers, and many European and global brand owners and food processors, only include suppliers certified to the BRC Global Standard for Food Safety in their supply chain.

The BRC Global Standard for Food Safety enables your organization to:

Provide evidence of commitment

In the case of a food safety incident, ensure legal protection under the concept of due diligence.

construct and operate a management system capable of helping Organization to better meet quality / safety requirements and food meet legal compliance, with specific reference to the legislation applicable in the countries where the finished product is consumed

Provide a tool for improving food safety performance and the means to monitor and measure the performance of food security effectively

Facilitate the reduction of waste products, product redesign, and product recall

Have management of efficient supply chain by reducing second party audits and increase overall reliability of your supply chains.

John Steves has published many articles regarding ISO Certification. John has rich experience as a online publisher and prepared various Certification documents as per ISO guideline since large amount of years in his professional career.

Barcode Your Product: 3 Important Steps

The need for increasing compliance with regulatory and retailer requirements is one of the major concerns for product manufacturers today. They need to protect their operations from expensive coding errors or illegible barcodes. In order to comply with applicable coding standards and guidelines, manufacturers need to opt for the right marking solution to meet their coding needs. The right choice of marking fluids, such as Videojet replacement inks, plays a crucial role when it comes to barcoding products. Besides choosing the ink, barcode users are required to follow some important steps to print data on their merchandise. Here are three of the most important ones:

1. Obtaining a GS1 Company Prefix

Before you start using barcodes, it is obligatory to allocate the numbers that go into the barcode. These numbers are known as GS1 identification keys. The most important step towards assigning these numbers is to get a GS1 company prefix. You need to obtain it from a GS1 member organization. As far as a GS1 company prefix is concerned, they help companies or manufacturers to create identification numbers for products, locations, logistic units, coupons and assets. Companies from all across the world use GS1 prefixes, unique numbers to identify items in the entire supply chain.

2. Choose the Right Barcode Printing Process

To begin, you need to ascertain which products you are barcoding and whether the barcode will have static or dynamic information in it. If you want to display static data, you can print the barcode by using conventional printing process. If the barcode displays dynamic information, you will require a combination of traditional and digital printing or simply digital printing. For instance, if your product requires a barcode with dynamic information and multi-color graphics, you can print the graphics with traditional printing presses. Leave an empty section for the product label for digital printing inline throughout the packaging and production process. You can even print a barcode with static information on a product package, employing digital printing. This is applicable if you are using similar packaging for a range of products.

3. Selecting a Barcode Color

Usually, the ideal color combination for barcode printing consists of black bars with a white background. However, you are always free to use other colors. Here are some ideas to help you:

If you are using GS1 barcodes, opt for dark shades for the bars, including dark blue, black, dark green or dark brown.
If you want to use several layers of the marking fluid to enhance background opacity, use quality Videojet inks and ensure that each layer is marked as a solid color.
The bars must always comprise of a single line color. Never print them using multiple imaging tools such as screen, plate or cylinder.
As far as GS1 barcodes are concerned, they need lighter backgrounds for the ‘Quiet Zones’. A Quiet Zone means the printing area around the white spaces and the barcode.
Sometimes, the symbol background is not printed. In such cases, the color of the packaging material or substrate serves as the barcode background. If you print the symbol background underneath the bars, the background must show solid line colors.