Stephanie McArdle’s default image

By: Stephanie McArdle

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted medical device manufacturers to send the FDA an accounting of device injuries and malfunctions on a periodic basis (e.g., quarterly or annually) in lieu of fulfilling their standard public reporting obligations. The ASR program actually ended in 2017, but evidence shows that device exemptions were still accepted by the FDA.

Grant Ramaley’s picture

By: Grant Ramaley

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region. 

This could be more problematic for dental products, which are inherently lower risk. Rubber dams and dental operating lights will have to comply before MRIs and pacemakers. 

To ensure that medical device manufacturers of class 1 devices understand that they must comply immediately on May 27, 2020, when the new regulation goes into effect, the European Commission states this plainly in its “Fact Sheet to Medical Device Manufacturers.”

Multiple Authors
By: Chad Kymal, Gregory F. Gruska

During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through a cooperative effort of North American vehicle manufacturers and their suppliers.” In the late 1980s, U.S. automotive suppliers, through the auspices of the American Society for Quality (ASQ), approached the VPs of purchasing for GM, Ford, and Chrysler and explained the burden of multiple standards that were being imposed on the supply base. Not only where there multiple OEM standards, there were hundreds of tier one standards as well.

Jyoti Madhusoodanan’s picture

By: Jyoti Madhusoodanan

A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot. Such logos are stamped on labels of coffee, cocoa, mangoes, jeans, and myriad other products, certifying that the object for sale is in some way “sustainable”—made, in other words, in a way that meets humanity’s needs without jeopardizing the ability of future generations to meet their own.

Rick Gould’s default image

By: Rick Gould

Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new sustainable treatment plants. The International Organization for Standardization (ISO) and the Gates Foundation have joined forces to show how clean toilets and standards can change people’s lives forever.

Jon Speer’s picture

By: Jon Speer

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

If your company was already compliant with the Medical Devices Directive (MDD), don't be fooled into complacency: The MDR represents brand-new regulations with significant changes.

For those seeking to better understand why the regulations have changed, and what some of the major changes are, let’s take a look at some of the most common questions we hear from our users.

James J. Kline’s picture

By: James J. Kline

The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have been written on how to implement ISO 9001:2015 in the private sector, little has been done with regards to the public sector.

This reflects two facts. First, the idea of systematically managing the risks governments face is relatively new. Second, where risks are being managed by government organizations, there is no consistent approach. Some are using ISO 9001:2015 and others are using ISO 31000. ISO 31000, revised in 2018, is an enterprise risk management standard.

This article looks at what public-sector organizations are thinking about, and doing, to manage risks.

Ryan E. Day’s picture

By: Ryan E. Day

In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies are involved in developing them. In this article, we’ll outline four points that can help your organization integrate standards into your operations.

Once you’ve decided which standards are applicable to your needs, the question becomes whether your team will benefit from centralized access to standards, and how you will manage updates and collaborate. There are basically two ways to license standards: single-use purchase, and subscription. Each has its own pros and cons.

Ronda Culbertson’s picture

By: Ronda Culbertson

The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new standards caught quite a few organizations somewhat flat-footed; particularly with the emphases on risk management and top-management participation (leadership). Getting it right is important; certification to one of the standards is rapidly becoming a requirement of the aerospace and defense industry.

The updated standards have proven challenging for small to midsized supplier organizations that need certification to advance their positions in the global supply chain. Even for larger companies and the major OEMs, the new revision of the standards is demanding.

Much like recent updates to core ISO standards (ISO 9001, ISO 14001, and ISO 45000), the revisions to AS9100, AS9110, and AS9120 demand a broader view of quality and organizational impacts. Some of the changes are very specific and technical; others are conceptual.

Multiple Authors
By: Alexandra Killewald, Xiaolin Zhuo

Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives.

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