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Face Mask Regulations and Standards in the EU: An Overview

There are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV. Quality Management System (ISO 13485) If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place.

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COVID-19 FDA Exemptions Due to Mask Shortages in the United States. Due to the current situation, the FDA is currently accepting the import N95 respirators that aren’t approved by NIOSH, but which are approved by authorities in the EU, China, Japan, Korea, Mexico, Australia, or Brazil.

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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List of Notified bodies accredited for Medical Device CE ...

A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Manufacturers can choose any notified body for conformity assessment (audit ...

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Coronavirus Hospital Supplies

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Export Certificates - Food and Drug Administration

U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

SGS | When You Need To Be Sure

SGS is the world's leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity.

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UL Standards Testing & Certification - UL Testing Labs.

We partner with SGS, who is a Nationally Recognized Test Lab (NRTL) in order to provide our clients with product certification to the UL standards. F2 Labs would perform all certification testing to the UL certification requirements and perform the factory inspections, as well. United States …

Certification Services – Medical Device Testing

Our Eurofins Medical Device Testing’s Certification Services help manufacturers gain access to global markets in a cost and time efficient manner. Services include Global Market Access, NRTL, SCC, Health Canada, FDA reports, Notified Bodies, CB Scheme, ISO 13485 audits & MDSAP.

Our Philosophy - Eurofins Medical Device Testing

Precision. Proficiency. Proximity. These three simple words comprise the most important elements of our Medical Device testing. Precision – Accuracy in testing is paramount to ensuring product safety and efficacy. And fast turnaround times are critical to keeping your project on schedule.With the highest level of instrument technology available in the industry, Eurofins Medical Device ...

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Export Certificates - Food and Drug Administration

U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

Coronavirus Hospital Supplies

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ISO 13485 Quality Management - Eurofins Medical Device …

Eurofins Medical Device Testing operates as accredited Certification Bodies according to ISO 13485 Quality Management System (QMS) for Medical Devices and Medical Electrical Equipment in accordance with the Medical Device Directives (MDD) 93/42/EEC, 2007/47/EC & 98/79/EC.

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Medical Devices | FDA

Medical Devices and the COVID-19 (Coronavirus) Pandemic Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face ...

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Mar 23, 2020 · The "Medical Device Testing and Certification Market - Growth, Trends, and Forecast (2020 - 2025)" report has been added to ResearchAndMarkets's offering.. Medical devices are subjected to comply with strict regulatory protocols, as it is vital to ensure the efficacy and safety of medical devices.

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About us

The test report has been approved by more than 70 countries and regions including the United States, Britain and Germany. Baotesta has a group of senior engineers who have been working in the testing and certification industry for 15 years and a professional sales team, so that your products can reach the world smoothly in the shortest time ...

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Company Overview - Eiffel Medical Supplies Co., Ltd.

211 south river ridge cir suite 101 Burnsville, MN, United States 1 - 888 - 345687 Office 605, 6th Floor, Main Shahrah Faisal, Karachi, Pakistan, Pakistan

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