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Recognized Consensus Standards

Created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards. Modifications to the list of recognized consensus standards: Publications in the Federal Register to the ...

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Safety & Performance Testing – Medical Device Testing

Safety & essential performance testing for medical electrical equipment & in vitro diagnostic medical devices in accordance with IEC 60601 and IEC 61010-2-101, respectively for global compliance with the Medical Device Directive (MDD) 93/42/EEC & IVD 98/79/EC.

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Medical Devices | Life Sciences | SGS

No matter the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.

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If susceptible persons must enter the rooms of patients known or suspected to have measles (rubeola) or varicella (chickenpox), they should wear respiratory protection. 5; FDA. The Food and Drug Administration (FDA) is responsible for regulating medical devices. A medical device is defined in section 201(h) of the Federal Food, Drug and ...

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AAMI Main Page | AAMI

The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 professionals united by one important mission—the development, management, and use of safe and effective health technology.

COVID-19 Update: ITMF study shows impact of coronavirus ...

Regarding the filtering effect, the certification process is currently underway for a medical standard for both mask types. To ensure a fast use of the face masks in Germany, KARL MAYER equipped a customer with the required machine technology and the instructions for the production of the masks.

Inspections | UL Consumer and Retail Product Services

Top of Production Inspections (TOP) — Before full production, UL’s inspection team will evaluate the first 200 units produced to ensure compliance with necessary criteria. During Production Inspections (DUPRO) – UL’s product inspections take place once a minimum of 20%, but no more than 40% of finished goods are produced to ensure ...

ISO 9001:2015 - What is the 9001:2015 Standard? | ASQ

ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard ...

Home | DuPont

We’re proud to provide personal protective equipment, infection and disease protection, thermal and electrical protection, and clean processes to protect workforces around the globe. Environmental protection. We help provide clean water to communities, increase the energy efficiency of products, and reduce waste by maximizing current resources.

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Another important federal immunity protection associated with treatment offered to COVID-19 patients is found in the 2005 Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. 247d-6d. This Act empowers the Secretary of Health and Human Services (HHS), through written Declaration, to provide that a "covered person," including a ...

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Product Recalls | SGS

Our Product Recalls online platform brings together the latest unsafe product notifications (non-food) published by official authorities operating in the European Union (RAPEX and RASFF) and United States (CPSC and FDA) since January 1, 2019. Access pertinent and insightful data instantly to understand and manage risk within your own organization.

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TÜV SÜD Global Home - Add value. Inspire trust. | TÜV SÜD

TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions. Over the last 150 years, we have added tangible value to our partners and customers through a comprehensive portfolio of testing, certification, auditing and advisory services.

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Environmental XPRT - The Environmental Industry Online

Americana — the leading multi-sector event in North America — is a prime meeting place for environmental professionals to discuss technical, scientific and business topics regarding key issues in the environmental sector. Americana is a biennial event organized since 1995 by Réseau Environnement, the largest network of environmental ...

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Eco-Friendly Skin Care: 20 Companies that are Leading the Change. Natural products are popping up all over the skincare and beauty industry. It’s one of the quickest growing markets among hygiene and cosmetic products. This beauty trend has developed alongside a widespread suspicion of mass-produced goods, including processed foods.

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Insights and Perspectives for Your Sustainability Journey

President Richard Nixon and the U.S. Congress on January 1, 1970 moved to pass the National Environmental Protection Act – which created the U.S. Environmental Protection Agency (EPA). Then came passage of Clean Water Act (1972), Clear Air Act, Endangered Species Act , RCRA (waste), SuperFund (CERCLA -1980), Wilderness Act (1974) and many ...

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Cosmetics and therapeutic goods - NICNAS

Skin-whitening products — cosmetic or therapeutic good? Products that produce a skin-whitening effect by colouring the skin may be regulated as cosmetics.. If the following applies to your product, the product is not a cosmetic and it may be regulated as a therapeutic good:. The product influences, inhibits or modifies a physiological process to produce the skin-whitening effect.

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Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese. Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical …

Understanding the Cosmetic Regulations in Australia

In Australia, there is a clear distinction between the definition of a cosmetic and a therapeutic good (including drugs and medicines). Cosmetic products are defined under the Industrial Chemicals (Notification and Assessment) Act 1989 and the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991 as:

Inspections | UL Consumer and Retail Product Services

Top of Production Inspections (TOP) — Before full production, UL’s inspection team will evaluate the first 200 units produced to ensure compliance with necessary criteria. During Production Inspections (DUPRO) – UL’s product inspections take place once a minimum of 20%, but no more than 40% of finished goods are produced to ensure ...

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Another important federal immunity protection associated with treatment offered to COVID-19 patients is found in the 2005 Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. 247d-6d. This Act empowers the Secretary of Health and Human Services (HHS), through written Declaration, to provide that a "covered person," including a ...

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Romer Labs | Food and Feed Safety | Diagnostic Solutions

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Carestream Contract Manufacturing offers precision contract coating and development services specializing in the application of aqueous and solvent coatings on flexible substrates for a wide range of industrial, medical, electronic and other advanced materials applications. About Carestream. A dynamic imaging and IT leader with more than 100 ...

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