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Intertek notified body
Intertek notified body. At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. Tel : 01277 321234 / 07875 633460. with MDR • Device(s) fall within MDR designation of IMNB • Provision of budget estimate for potential client • Choice to request a formal application package May 19, 2020 · The Swedish company Intertek announced on 15 May 2020 that Intertek Medical Notified Body AB (IMNB) has been designated as the 14th Notified Body against the EU Medical Device Regulation 2017/745 (MDR). Brentwood, UK: Intertek, a leading total quality assurance provider to industries worldwide, is pleased to announce that Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA). All accreditations are granted to the legal entities operating within Intertek. Intertek SEMKO AB, NB 0413, is not registered under the PPE directive in NANDO. Intertek Medical Notified Body ABTorshamnsgatan 43, Box 1103SE-164 22 KistaCountry : Sweden Notified Body number : 2862 Thanks to its Notified Body status, Intertek Italia Spa can perform the conformity assessment on your PPE and issue the certificate for the EU Type examination (Module B) for the following product categories, as reported in NANDO website: • Equipment providing buoyancy aid • Equipment providing chest and groin protection You can benefit from the IECEx System’s objective on cutting certification costs and speeding turnaround times. Get Faster and Affordable CE Certification. Medical Device certification under the Medical Device Regulation MDR (2017/745) is offered through our legal entity Intertek Medical Notified Body AB (IMNB AB), Notified Body Number NB 2862. E. As a leading global Assurance, Testing, Inspection, and Certification provider, Intertek can offer Global Market Access services for the (U. U Initial registration: May 17, 2024 Date of expiry: December 31, 2024 Issue status: 1 This certificate was first issued on May 17, 2024 and will remain valid as long as neither the harmonised standard, the construction product, the AVCP Jul 24, 2018 · Ian Galloway, Executive Vice President Middle East, Africa and Global Trade at Intertek, said: “Through our global and local outreach of accredited certification bodies, test laboratories and technical experts, Intertek offers assurance, testing, inspection and certification for multiple industries in the region. Information about bodies including their contact and notification details can be found in section Notified bodies. , CIF Designation of a notified body. Intertek has been appointed in the UAE as a Notified Body for Low Voltage Equipment (LVE), Energy Efficiency Standards Labelling (EESL), lighting regulation, regulation for restriction of hazardous substances (RoHS) and equipment used in explosive atmospheres (ECAS Ex), Cosmetics, Perfumery and Personal Care Products (TR UAE GSO 1943) and is Intertek is an accredited Notified Body (NB0007) by ESMA to conduct Certification activities under the ECASEx program. Audits in around 6 months (updated 12/2022) QMS Software List Notified Body Reviews Community Conference 2021. U Initial registration: August 15, 2024 Date of expiry: December 31, 2024 Issue status: 1 This certificate was first issued on August 15, 2024 and will remain valid as long as neither the harmonised standard, the construction product, the AVCP Feb 14, 2020 · February 14, 2020. The requirements that need to be considered for each battery category are: Battery passport The Medical Device Single Audit Program (MDSAP) was developed by a group of medical device regulators, the International Medical Device Regulators Forum (IMDRF), to allow third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements. Intertek Deutschland GmbH is accredited for the following directives: Noise Emission in the Environment Directive; Toy Safety Directive; Machinery Directive; Construction Products Regulation; Sweden INTERTEK MEDICAL NOTIFIED BODY AB Client inquiry related to MDR certification Client completes online form –either for budget estimate or formal application Intertek sends budget estimate Client fills in application documents (CIF and Device List) Filled in documents Quotation (contract proposal) Review of application documents (e. A. May 4, 2016 · 04 May 2016. Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA). Relevant resources at AMTAC will also transfer to report into Semko, but remain at current locations. The Commission publishes a list of designated Notified body: Intertek Iberica S. Hong Kong May 3, 2016 · 03 May 2016. Chicago - Intertek, a leading quality solutions provider to industries around the world, announces the addition of its laboratory in Mexico City to its list of notified bodies able to test and certify low-voltage electrical products for the Gulf mark (G mark) scheme. Accreditations, Affiliations and Recognitions: Accreditations for Americas Accreditations for Asia Pacific Apr 2, 2019 · Triple Notified Body status for Intertek Italia. Intertek is an ATEX Notified Body, accredited by UKAS (UK) and Accredia (Italy), and our many years of experience certifying equipment used in Hazardous Locations and Explosive Atmospheres includes extensive ATEX Directive 2014/34/EU expertise. The Medical Devices Regulation (MDR) 2017/745 requires that the Notified Body undertakes (for products of classification IIA, IIB and III) a review of the Technical Documentation from the manufacturer as either part of the initial certification process, as part of surveillance, recertification and / or as part of significant change notifications. The International Accreditation Forum, Inc. Intertek Medical Notified Body AB (the "NB") Intertek Medical Notified Body UK Ltd (the "UKAB") Impartiality & freedom from conflicts of interest It is of the utmost importance that the NB and UKAB provides its services to all interested parties without favor or discrimination, and that its decisions are not capable of being influenced by any Intertek is the industry leader, with employees in 1,000 locations in over 100 countries. Notified Body - Medical Device CE Marking. S. Notified Body Status. Udine: Intertek, a leading Total Quality Assurance provider to industries worldwide, has earned ISO 17065 accreditation from Accredia, the national accreditation body for Italy, becoming a Notified Body under the ATEX Directive, GAR Regulation and BED Directive. Intertek’s UK Notified Body, AMTAC (NB No 0473), will be gradually phased out and eventually closed by 1 July 2018. Chicago (December 23, 2015) - Intertek, a leading quality solutions provider to industries around the world, has received formal approval as a notified body by the Gulf Standards Organization (GSO) and Gulf Cooperative Council (GCC) to test and certify products for the Gulf Mark (G Mark) scheme. Jun 8, 2022 · Notified Body. Are you looking for a new Notified Body to partner with? Frequently Asked Questions: Intertek Medical Notified Body (IMNB) is designated under Medical Device Regulation (MDR) 2017/745. Confirm that the device(s) covered by this application is/are a medical device according to the definition in Article 2, (1) of 2017/745 MDR, ‘Medical Device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical Intertek Medical Notified Body (IMNB) supports you along your compliance journey with a long history of excellence and expertise. The headquarters for IMNB AB is in Stockholm, Sweden. Oct 24, 2011 · 24 Oct 2011. , enabling localized certification services for clients manufacturing equipment for explosive atmospheres in the European Union. Ltd, M/s TUV Rheinland India Pvt. Mar 30, 2022 · Intertek Reviews & Capacity. Download our brief to learn more about auditing and certification services. Intertek is your Trusted Partner for Assurance solutions that not only meet your requirements but also exceed your expectations, solidifying your position as a leader in your industry. May 3, 2016 · 03 May 2016. Intertek has five European Union-based Notified Bodies located across Germany, Sweden, France, Spain and the United Kingdom. Germany. Receiving the UKAS accreditation is a major milestone and a pre-requisite for designation as a UK Approved Body. Intertek Capacity. We combine comprehensive internal capacity, direct contact with your file assessors, as well as the ability to combine audits and certifications. Intertek is a leading provider of comprehensive quality assurance services. *Intertek does not provide consulting services for management systems certification. Whether your business is local or global, we can help to ensure that your At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. Our product directories allow you to easily verify products that carry our marks. com Intertek Medical Notified Body. See full list on intertek. com. As of December 2019, there are eight notified bodies based in India, which have been registered with the CDSCO. The conformity assessments are performed through various evaluation procedures that apply depending on the pressure equipment category. We have the product expertise and full capability to test to a variety of directives, including: ATEX Directive (94/9/EC) Construction Products Regulation (CPR) EMC Directive (2004/108/EC) Intertek Medical Notified Body is part of the Code of Conduct for Notified Bodies in Europe and our scope of designation can be viewed on the Nando website. Edmonton, Alberta – Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce the approval of its first lab in Canada as an ATEX notified body, providing Canadian manufacturers of equipment used in explosive atmospheres with a testing and certification partner to access the European market. Market surveillance (ICSMS) Information and Communication System for Market Surveillance (ICSMS) is the comprehensive communication platform for market surveillance on non-food products and for mutual recognition for goods. Here we list some of the EU countries where Intertek is accredited as a notified body, and for which directives. . The European Union recognizes that products vary greatly in their ‘risks’ to the users and the public. Intertek is a notified body and can provide compliance services for all machinery and safety components (including hoverboards which the EU consider as machines, and as such will be evaluated under the requirements of the machinery directive) named in Annex IV of the Directive. With 30 years of extensive experience in the industry, we pride ourselves on being a trusted partner for countless medical device manufacturers. Stockholm, Sweden - Intertek, a leading Total Quality Assurance Provider to industries, is pleased to announce that the Intertek Medical Notified Body AB (IMNB) has been designated against MDR 2017/745 from the Swedish Competent Authority. L. Ltd, and M/s TUV Sud South Asia Pvt. Dec 23, 2015 · 23 Dec 2015 Approval Granted to Facilities in Shanghai, Hong Kong and Singapore. Elevenborgsvägen 2, 230 53 Alnarp . Jul 2, 2024 · INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532) Academy Place 1-9 Brook Street Brentwood Essex CM14 5NQ Contact: Sharmila Gardner. Aug 17, 2023 · The CE conformity assessment is a self-certification process for portable batteries and industrial batteries with a capacity of less than 2 kWh. Intertek's ATEX Certification Solutions. Notified Body - 0005 . Dubai, UAE - Intertek, a leading Total Quality Assurance provider to industries worldwide, has been designated as a “Notified Body” by the Gulf Standards Organization (GSO) to issue Gulf Conformity Mark (G Mark) Certificates to locally-produced, imported and exported products across the Gulf countries. Intertek have seen false ‘certificates’ on letterheads, or the use of Intertek’s logo and/or name and Notified body number 0413, as the basis for CE marking against the Medical Device Directive or Personal Protective Equipment Directive. Notified body: Intertek Iberica S. May 28, 2021 · 28 May 2021. Please contact the respective accreditation body or the contacts listed below for further details. Intertek is accredited for most of the Technical Regulations in the Europe, MENA, Americas, and Asia regions and Importers can select one of Intertek’s four (4) Accredited Offices to facilitate Conformity Assessment and Certificate issuance. imnb@intertek. Medical Device News. With the goal of facilitating international trade of equipment and services intended for use in explosive atmospheres the IECEx system provides one international database listing. Intertek is an accredited Notified Body for the Pressure Equipment Directive 2014/68/EU and can provide the conformity assessments necessary for your equipment’s certification. Ltd. Intertek ScanBi Diagnostics. To be designated, a candidate organisation must fulfil specific requirements on organisational aspects, quality management, resources and processes verified by national authorities responsible for notified bodies with the involvement of other European experts. Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. Dec 14, 2020 · Some of the largest companies like the SGS are designated as Notified Body in several countries and can provide services for a large array of products, such as: Electronic equipment; Medical devices; Hot-water boilers; Machinery; Construction products; As another example, Intertek is designated as a Notified Body for the following class of Intertek is an accredited Notified Body (NB 0007) by ESMA to operate certification activities under the ECAS program. Email: IMNB@intertek. Phone: +46 40 69 Feb 24, 2020 · 24 Feb 2020. Previously in May 2018, the CDSCO had approved three notified bodies to operate in India, namely M/s Intertek India Pvt. Chicago – Intertek, a leading provider of quality solutions to industries worldwide, announces that it has extended its notified body status under the ATEX directive to reviewers in two laboratories in the U. As a leading global provider of assurance, testing, inspection, and certification services with a network of expertise and laboratories worldwide, Intertek has Aug 24, 2023 · 24 Aug 2023. Jun 9, 2023 · The scope of our accreditation can be found here on the UKAS website: Intertek Medical Notified Body UK Limited. For more information on Intertek's SWEDAC accreditation and Notified Body, please visit our intertek. All accreditations are globally recognised and accepted. *The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Explore our broad array of capabilities and how our team of experts has become a trusted resource for the global medical Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. , where our Notified Body number NB 0413 is located for MDD. Our expert team has the required technical competencies to provide full support in this regard. (IAF) details criteria for the accreditation of bodies that provide conformity assessment services, and such accreditation facilitates trade and reduces demands for multiple conformity assessment activities cross border. Leicester, England & Heudebouville, France – Intertek, a leading provider of quality and safety services to a wide range of industries around the world, announces that its network of consumer goods testing laboratories now includes two European locations approved as notified bodies to conduct EC-type examinations and issue EC-type certifications. 2/F Garment Center , 576 Castle Peak Road ,Kowloon , Hong Kong . As a Notified Body in the EU, Intertek's scope covers products that require the highest category of validation - (AVCP System 1) which must involve the independent expertise of a Notified Body, and an FPC (Factory Production Control) audit. g. ** The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. IMNB UK anticipate achieving the UK Approved Body designation from the MHRA during Q3/2023. Feb 15, 2018 · Intertek will transition its European Notified Body Medical activities to Intertek Semko AB (NB No 0413) in Kista, Sweden. Use of pre-application form via INTERTEK MEDICAL NOTIFIED BODY webpage • Preliminary verification that • Device(s) are covered by MDR • Classification in acc. com (Intertek Medical Notified Body) Division: Regulatory Services. Each accreditation has a defined scope and is site-specific. se Swedish website. Intertek Medical Notified Body | Choosing the Right Notified Body; ISO 13485 | Quality Management Systems for Medical Devices; ISO 22716 | Good Manufacturing Practices for Cosmetics; MDR 2017/745 | EU Medical Device Regulation; Medical Device Single Audit Program (MDSAP) UKCA for Medical Devices | UK Market Access Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. The Machinery Directive also contains requirements for risk analysis. May 15, 2020 · 15 May 2020 MDR is a new set of regulations for the manufacturing of medical devices in the EU. For all other batteries, a notified body will need to be involved when the regulation is in full effect. ) ECASEx program via application to/by Intertek’s network of Ex laboratories and Ex May 10, 2017 · From the widely recognized ETL mark and OSHA NRTL approval for North America, to ATEX notified body status for Europe and IECEx certification for global markets, Intertek’s team of engineers and technicians have the experience and know-how to help with the certification process and provide training and technical service solutions designed Dec 23, 2015 · As a notified body, Intertek is a recognized conformity assessment body, accredited under ISO 17065 and notified by a national government authority to be deemed competent to conduct product Apr 5, 2016 · As a G mark notified body, Intertek has been recognized as a conformity assessment body, accredited under ISO 17065 and notified by the GSO and GCC to be deemed competent to conduct product verification and certification to the G mark standards. Intertek Testing Services Hong Kong Ltd Address. 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.
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