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Italy: Medical Masks Without CE Marking | Insight | Baker ...

Mar 27, 2020 · The National Health Institute and Confindustria Dispositivi Medici (the Italian Association of Medtech Companies) jointly developed a technical datasheet identifying essential requirements for the placing on the market of surgical masks for medical use not bearing the CE marking pursuant to Article 15 of Decree Law No. 18 of March 17, 2020, so ...

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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 ...

Medical Devices | Life Sciences | SGS

As the world’s largest inspection, verification, testing and certification company, we provide clients with a market leading, global network of medical device offices, laboratories and experts. Operating in over 35 countries, we offer global and local solutions to meet your …

Notified Body Services - Medical Device Certification

Medical Device Directives. In order to bring medical devices to the European (EU) market, manufacturers must earn a CE Mark to confirm compliance with the Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC; or in the case of in vitro diagnostic medical devices, the In Vitro Diagnostics Directive (IVDD) 98/79/EC.. These CE marking Directives cover active ...

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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.

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Other testing and certification services - TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC) . Your benefits at a glance. Recognised medical device expertise - TÜV SÜD Product Service is ...

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Medical Devices | BSI Vietnam

It is essential that your certification body has the capability and expertise to support you with robust product and system certification reviews, to ensure patient and user safety. Maintaining quality, delivering excellence. BSI Medical Devices offers certification services to …

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5.Q: Do your company have any quality management system such as ISO, EN or CE certificate(s)? A:AOK has passed the IS09001 2008 quality system certification, and has passed the GTTC certification (T/CTCA 7-2019), the US Disney inspection. 6. Q: How do you solve quality issues if happened?

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Apr 01, 2020 · Not only medical companies, but also other businesses, private consumers and even governments are buying up newly produced face masks in a very short time and in large quantities. Several local authorities have also introduced compulsory wearing of face masks in certain public places such as supermarkets.

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Surgical Disposable Supplies Manufacturer - SMS

SoMedical Supplies Co., Ltd. is a professional medical-surgical disposable protective supplies factory based-in China with 10 years of experience. We offer a variety of disposable protective products, such as disposable face masks, gowns, coverall, overall, SMS bed sheet, caps, shoe cover, etc.

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Medical-surgical disposable protective face mask; Bacterial filtration efficiency ≥99%; Particular filtration efficiency ≥99%; Effectively isolating bacteria, pollen, dust, and haze. CE, FDA, ISO13485; ASTM F2100 Level 1/2/3; EN14683 TYPEI II IIR; Customized material, color and size are available.

ISO 13485 Certification - What Is the ISO 13485 Standard?

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference ...

Medical Device Registration in Russia - Emergo

In January 2016, the Eurasian Economic Commission (ECC) released a new regulatory system for medical devices, the Eurasian Medical Device Registration Rules (ERR). The ERR is intended to harmonize the requirements between countries and establish a common market, similar to the EU's CE …

Security | ESW Vision

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3 ply Surgical Disposable Face Masks Manufacturer - SMS

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ISO 13485 Certification - What Is the ISO 13485 Standard?

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference ...

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Medical Device Registration in Russia - Emergo

In January 2016, the Eurasian Economic Commission (ECC) released a new regulatory system for medical devices, the Eurasian Medical Device Registration Rules (ERR). The ERR is intended to harmonize the requirements between countries and establish a common market, similar to the EU's CE …

Security | ESW Vision

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Brazil - Inmetro Decree 102/2020 Suspending the Mandatory Ce

The Inmetro Decree No 102/2020, considering the need to maintain an adequate supply of medical hospital supplies to face the coronavirus pandemic (COVID-19), in order to facilitate its rapid manufacture or import and distribution throughout the country is suspending the mandatory certification of the following:- Surgical Gloves and Non-Surgical Procedure of Natural Rubber, Synthetic Rubber and ...

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EMI Test Lab. com FCC - CE Mark Testing and Design Consulting Contact Dennis King at [email protected] – (303) 684-6650 . Overall Summary of the CE Mark Process A typical computing product 1. Determine if your product requires a “Notified Body” Lab or …

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Medical masks have to meet the requirements of the Medical Device legislation and comply with standard EN 14683: Medical face masks - Requirements and test methods and shall have a CE-mark. Currently, it is not necessary to contact a notified body (which is …

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Chile Medical Device Regulations | RegDesk

In general, it is not required to register medical devices, however, it is recommended that they have a voluntary certification. Appoint an authorized representative (AR) in Chile. Provide information including name of AR and verification of conformity. ISP will conduct an audit to …

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PPE – Protective Gloves | Consumer Goods and Retail | SGS

To sell gloves as Category II PPE, to protect against mechanical risks, they must meet the EN 388 and EN 420 standards. Manufacturers, or their authorized representatives, in the European Community must also submit technical documentation, including product samples for testing, to a Notified Body for EU type examination under the EU’s Personal Protective Equipment (PPE) Regulation, 2016/424.

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Medical | Pall Corporation

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