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Workshop to Address Medical Device Regulatory Changes

TÜV SÜD will host a…

TÜV SÜD will host a workshop in March to help manufacturers understand the changing medical device regulatory landscape as a result of the upcoming overhaul of the European Union’s Medical Device Regulation and Approval Process (MDR).

The 2017 MDR Workshop will take place on March 13 at the Kimpton Palomar Hotel in San Diego, California. It will be led by Dr. Bassil Akra, TÜV SÜD’s global director of clinical centers of excellence,

Dr. Akra has a distinguished career in research and development, quality management, and regulatory affairs. He is deeply involved with the development of the EU’s guidance and standards in his capacity as a member of the working group on clinical investigation and evaluation.

Other speakers at the workshop will include Dr. Matthias Fink, Dr. Gerold Labek, and Dr. Yuan Li of TÜV SÜD.

The focus of the workshop will be the regulatory requirements surrounding complex Class III medical devices, such as orthopedics, implants, and those used in contact with the spinal column. Devices previously certified on an equivalence basis and without a significant amount of clinical data may not be certified under the new rules.

Overall, the MDR calls for increased standards for clinical evidence, more intensive documentation, an expansion of the scope of covered devices, and the implementation of unique device identification codes for better tracking of potential defects.

Registration for the workshop will open at 1:30 p.m. PST and the workshop will run from 2:00 p.m. to 6:00 p.m. A group reception and networking buffet will follow. Click here for more information on the workshop.

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ANSI Seeks Comments on New ISO Field of Consumer Vulnerability

Interested in consumer vulnerability? ANSI…

Interested in consumer vulnerability? ANSI wants to hear from you.

The International Organization for Standardization (ISO) has circulated a proposal for a new field of activity for a new ISO standard to be titled “Guideline for inclusive service—identifying and responding to consumers in vulnerable situations.” As the U.S. member body to ISO, ANSI is seeking interested stakeholders to submit comments on the proposal by April 7.

The proposal, submitted by ISO’s Consumer Policy Committee (COPOLCO) and BSI, explains that the new ISO standard would provide guidance on how to identify consumers in vulnerable situations and how to develop, implement, and maintain policies and procedures for organizations to handle them.

Consumer vulnerability is any circumstance that puts consumers at greater risk when choosing or using products or services. A variety of factors contribute to consumer vulnerability—which might be long or short term, temporary, permanent, or sporadic—including debt, unemployment, old age, mental health issues, and physical impairments.

An international standard would help organizations minimize consumer risk by:

  • Raising awareness and understanding of consumer vulnerability.
  • Giving guidance on how to identify consumers in vulnerable circumstances.
  • Establishing processes and procedures that will help organizations respond to consumers in vulnerable situations.

All interested stakeholders are invited to review the proposal, which includes a listing of relevant documents at the international, regional, and national levels, and stakeholder categories that may benefit from by the proposal. View it on ANSI’s website.

The post ANSI Seeks Comments on New ISO Field of Consumer Vulnerability appeared first on The Auditor.

Enhancing Traceability with a New ISO Project Committee

How do you know that…

How do you know that your bottle of champagne is the real McCoy? That your boots were really made in Italy or that your milk is indeed pasteurized? Traceability—known as chain of custody—is important for ensuring the authenticity, and therefore the quality and safety, of virtually every product imaginable. A new ISO committee has just been formed to make it easier.

From raw materials such as cotton to the T-shirt in your favorite shop, knowledge and tracking of the specific product characteristics (e.g., origin, sustainability traits and/or manufacturing process) is increasingly important and demanded by consumers. Traceability, and hence transparency, provides reassurance and a better understanding of production characteristics in order to reduce risks to health, safety, and quality. In many cases, it is even a legal requirement. A reliable chain-of-custody (CoC) management system is therefore important for certification and quality assurance schemes.

The world is awash with CoC systems and programs, all with their own semantics, presentation, and industry focus, and include CoCs for food safety, sustainable agriculture or compliance in manufacturing. But the sheer number of such systems adds unnecessary layers of administration, thereby increasing costs and pushing smaller companies out of international markets. It is with this in mind that a new ISO project committee—ISO/PC 308, Chain of custody—was established, making traceability simpler for all supply chain actors by using a uniform ISO language globally.

Chair of ISO/PC 308 Rob Busink said: “The proliferation of traceability systems and definitions is causing unnecessary confusion, complexity and costs for players in different supply chains. The proposed generic chain-of-custody standard will define supply chain models and the respective traceability levels and specific requirements related to administration, conversion rates and physical handling activities, thus simplifying market access by using a uniform language and criteria throughout the supply chain.

“It is hoped that existing and new certification schemes will be able to refer to the ISO standard for the terminology regarding chain-of-custody requirements, thus simplifying the conformity assessment for those various product certifications and reducing unnecessary duplication or misunderstanding.”

The committee has already attracted support for the development of the standard from organizations across many sectors, such as food, consumer goods, energy and construction, as well as certification schemes and government.

This article has been republished in full with permission from ISO.