Intertek notified body
Intertek notified body. All accreditations are globally recognised and accepted. with MDR • Device(s) fall within MDR designation of IMNB • Provision of budget estimate for potential client • Choice to request a formal application package Feb 5, 2024 · Intertek Medical Notified Body AB. 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. The Saudi Product Safety Programme (also referred to as SALEEM) is facilitated by SASO which has issued Technical Regulations for certain critical products such as lube oils, detergents, building materials and construction products, paints, lifts, vehicle spare parts, and textiles based on their nature, application, safety, and performance aspects. Explore our broad array of capabilities and how our team of experts has become a trusted resource for the global medical Frequently Asked Questions: Intertek Medical Notified Body (IMNB) is designated under Medical Device Regulation (MDR) 2017/745. Whether your business is local or global, we can help to ensure that your 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 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 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. The following PDFs have been updated: BSI Assurance UK Ltd Medical Devices Scope BSI Assurance UK Ltd Intertek Medical Notified Body ABTorshamnsgatan 43, Box 1103SE-164 22 KistaCountry : Sweden Notified Body number : 2862 May 4, 2016 · 04 May 2016. 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. EU Notified Bodies designated under the EU MDR (2017/745) 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. Intertek has five European Union-based Notified Bodies located across Germany, Sweden, France, Spain and the United Kingdom. Notified Body Status. 3. Feb 24, 2020 · 24 Feb 2020. 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. The headquarters for IMNB AB is in Stockholm, Sweden. , CIF Mar 30, 2022 · Intertek Reviews & Capacity. 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. This letter confirms that, Intertek Medical Notified Body AB, a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number 2862 on NANDO, has received a formal application in accordance with Section 4. Scope: Notified Body to MDD directive for medical products annex II, III, IV, V and VI ; Criteria: ISO/IEC 17025, ISO/IEC 17021, EN 45012; United Kingdom Accreditation Service (UKAS) - UK May 28, 2021 · We can help you to meaningfully demonstrate your commitment to sustainability and manage risk and resilience, whilst supporting your ability to operate effectively and act responsibly. Find company research, competitor information, contact details & financial data for Intertek Medical Notified Body AB of Kista, Stockholm. For all other batteries, a notified body will need to be involved when the regulation is in full effect. com (Intertek Medical Notified Body) Division: Regulatory Services. Designation of a notified body. Apr 2, 2019 · We can help you to meaningfully demonstrate your commitment to sustainability and manage risk and resilience, whilst supporting your ability to operate effectively and act responsibly. Our accreditations provide you with the confidence and peace of mind that your company is operating safely and adhere to regulation. com This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. You can benefit from the IECEx System’s objective on cutting certification costs and speeding turnaround times. The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not … shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards Aug 7, 2024 · The UK Market Conformity Assessment Bodies (UKMCAB) service is the definitive source and a register of UK Government appointed Conformity Assessment Bodies (CABs) who can certify goods for both the GB and NI markets. Whether your business is local or global, we can help to ensure that your Notified Body - 0005 . Ltd, M/s TUV Rheinland India Pvt. 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. Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and quality management systems. • Violate contract or agreement of certification. The requirements that need to be considered for each battery category are: Battery passport 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 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 Intertek is an accredited Notified Body (NB 0007) by ESMA to operate certification activities under the ECAS program. We combine comprehensive internal capacity, direct contact with your file assessors, as well as the ability to combine audits and certifications. 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. 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. se Swedish website. The Machinery Directive also contains requirements for risk analysis. Our product directories allow you to easily verify products that carry our marks. Medical Device News. 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. Learn more about this process or how to initiate an appeal to our Certification Body. As a leading global Assurance, Testing, Inspection, and Certification provider, Intertek can offer Global Market Access services for the (U. ** 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. The Commission publishes a list of designated Jan 12, 2024 · Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. Help us keep this information up to date. 2. ” The Business Assurance group of Intertek provides a full range of business process audit and support services, including accredited third-party management systems auditing and certification, second-party supplier auditing, and training services. A Notified Body is an independent laboratory or organization that has been accredited by national authorities and notified to the EU Commission (Intertek has three Notified Bodies). Receiving the UKAS accreditation is a major milestone and a pre-requisite for designation as a UK Approved Body. Medfield has entered into an agreement with Intertek for tests according to standard IEC 60601-1 with applicable substandard guidelines for pre-hospital use as well as CE certification under the Medical Devices Directive, MDD Annex II. With 30 years of extensive experience in the industry, we pride ourselves on being a trusted partner for countless medical device manufacturers. Feb 15, 2018 · Intertek will transition its European Notified Body Medical activities to Intertek Semko AB (NB No 0413) in Kista, Sweden. Download our brief to learn more about auditing and certification services. The conformity assessments are performed through various evaluation procedures that apply depending on the pressure equipment category. The International Accreditation Forum, Inc. g. Scope: Notified Body to LVD, EMC, R&TTE, Machinery Directive ; Criteria: ISO/IEC 17025; SWEDAC - SE. S. As a leading global provider of assurance, testing, inspection, and certification services with a network of expertise and laboratories worldwide, Intertek has Oct 24, 2011 · 24 Oct 2011. GSO Notified Body Examination Report Address Building No. See full list on intertek. 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. Get Faster and Affordable CE Certification. Aug 9, 2021 · Annex VII of that law restricts Intertek as follows: 1. Intertek is an accredited Notified Body (NB0007) by ESMA to conduct Certification activities under the ECASEx program. Elevenborgsvägen 2, 230 53 Alnarp . • Misuse of certification mark. Get the latest business insights from Dun & Bradstreet. Use of pre-application form via INTERTEK MEDICAL NOTIFIED BODY webpage • Preliminary verification that • Device(s) are covered by MDR • Classification in acc. Germany. 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. Jan 1, 2021 · Pdf attachment has been replaced for Intertek Medical Notified Body UK Ltd. 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. Ltd. 1 March 2024. Dec 23, 2015 · Assurance. As Notified Bodies are officially designated, we will add them here. 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 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). Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. Oct 24, 2011 · We can help you to meaningfully demonstrate your commitment to sustainability and manage risk and resilience, whilst supporting your ability to operate effectively and act responsibly. Jun 9, 2023 · The scope of our accreditation can be found here on the UKAS website: Intertek Medical Notified Body UK Limited. Certification Body Complaints And Appeals Process. Welcome, Curtis! 0:38 – 0:40 Curtis Riley, Head of Notified Body at Intertek Medical Notified Body – Business Assurance It's a pleasure to be here. TÜV Mar 28, 2018 · 28 March, 2018 Medfield is planning for CE-certification of Strokefinder MD100 together with Intertek as Notified Body. 3, first subparagraph of Annex VII of MDR and has Frequently Asked Questions: Intertek Medical Notified Body (IMNB) is designated under Medical Device Regulation (MDR) 2017/745 Case Study Intertek Cristal worked with the Qatar Ministry of Public Health to customize inspection services to the hospitality industry during the FIFA World Cup Qatar 2022™ event. 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. 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. Apr 2, 2019 · Triple Notified Body status for Intertek Italia. 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. May 10, 2024 · Joining me is Curtis Riley, Head of Notified Body at Intertek Medical Notified Body – Business Assurance. 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 provides safety and performance certification to nationally recognized standards for a wide range of products. 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. Intertek’s UK Notified Body, AMTAC (NB No 0473), will be gradually phased out and eventually closed by 1 July 2018. 86,1198 Qinzhou Road(North), Shanghai, China 200233 Telephone: 86-21-61278200 www. More for INTERTEK MEDICAL NOTIFIED BODY UK LIMITED (13964915) Registered office address Academy Place 1-9 Brook Street, Brentwood, England, CM14 5NQ Jun 8, 2022 · Notified Body. At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. Phone: +46 40 69 May 15, 2020 · 15 May 2020 MDR is a new set of regulations for the manufacturing of medical devices in the EU. Here we list some of the EU countries where Intertek is accredited as a notified body, and for which directives. 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. 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. This includes how well-organized the notified body was, technical proficiency of the auditor, wait times and cost. Previously in May 2018, the CDSCO had approved three notified bodies to operate in India, namely M/s Intertek India Pvt. The average Notified Body Medical Device Auditor base salary at Intertek is CA$100K per year. Intertek Deutschland GmbH is accredited for the following directives: Noise Emission in the Environment Directive; Toy Safety Directive; Machinery Directive; Construction Products Regulation; Sweden Audit Manager at Intertek Medical Notified Body AB · Experienced medical device industry Quality Assurance and Regulatory Affairs Manager <br>Energetic, perceptive people skills with a hands-on management style <br>Effective and clear interpersonal and communication skills<br>Good knowledge of ISO 9001, EN ISO 13485 & MDD 93/42/EEC for CE marking of Medical Devices and Feb 24, 2020 · We can help you to meaningfully demonstrate your commitment to sustainability and manage risk and resilience, whilst supporting your ability to operate effectively and act responsibly. 2/F Garment Center , 576 Castle Peak Road ,Kowloon , Hong Kong . Intertek SEMKO AB, NB 0413, is not registered under the PPE directive in NANDO. Intertek Medical Notified Body 2 of 3 • Product safety issues or lack of insufficient clinical evidence. Reviews of Intertek, a Notified Body in Sweden These are user-submitted reviews of medical device companies describing their experience working with this notified body. Audits in around 6 months (updated 12/2022) QMS Software List Notified Body Reviews Community Conference 2021. Intertek's responsibility and liability are Comite Europeen de Normalisation (CEN) • EU Competent Body ; EU Notified Body; Technical Adaptation Committee (TAC) United Kingdom Accreditation Service (UKAS) USA . , where our Notified Body number NB 0413 is located for MDD. 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 offers worldwide assurance, testing, inspection and certification solutions for different industries, including medical devices. 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. Furthermore, Intertek Medical Notified Body AB is designated as a notified body to certify medical devices in Sweden. Intertek is accredited to conduct testing in accordance with major industry bodies such as the Civil Aviation Authority (CAA) and Federal Aviation Administration (FAA). *Intertek does not provide consulting services for management systems certification. Notified Body - Medical Device CE Marking. Jan 25, 2024 · Intertek Medical Notified Body UK Ltd Body number 8532 Previous Body number(s) UKAS reference number 26341 Contact details 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. 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. Please contact the respective accreditation body or the contacts listed below for further details. 0:41 – 0:51 Natalia Farina OK, Let's dive right in. Email us with corrections or additions. Dec 23, 2015 · 23 Dec 2015 Approval Granted to Facilities in Shanghai, Hong Kong and Singapore. May 29, 2018 · Company Overview for INTERTEK MEDICAL NOTIFIED BODY AB (BR020469) UK establishment office address Academy Place 1-9 Brook Street, Brentwood, CM14 5NQ 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 Brand Logo. Intertek Medical Notified Body (IMNB) supports you along your compliance journey with a long history of excellence and expertise. • In case of providing false information or document during the conformity assessment activities performed by Intertek Medical Notified body. Feb 15, 2018 · February 15, 2018 Intertek, a leading Total Quality Assurance provider to industries worldwide, announces that it is centralising its Notified Body Medical Mar 30, 2022 · The estimated total pay range for a Notified Body Medical Device Auditor at Intertek is CA$95K–CA$105K per year, which includes base salary and additional pay. 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). As of December 2019, there are eight notified bodies based in India, which have been registered with the CDSCO. Aug 24, 2023 · 24 Aug 2023. Intertek is the industry leader, with employees in 1,000 locations in over 100 countries. intertek. American Apparel and Footwear Association (AAFA) American Association of Textile Chemist and Colorist (AATCC) American Association for Laboratory Accreditation (A2LA). Intertek is committed to a fair and transparent Complaints and Appeals process regarding our certifications. All accreditations are granted to the legal entities operating within Intertek. A. com Intertek Medical Notified Body. with MDR • Device(s) fall within MDR designation of IMNB • Provision of budget estimate for potential client • Choice to request a formal application package Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Intertek ScanBi Diagnostics. 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. Information about bodies including their contact and notification details can be found in section Notified bodies. The European Union recognizes that products vary greatly in their ‘risks’ to the users and the public. 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. Are you looking for a new Notified Body to partner with? May 28, 2021 · 28 May 2021. IMNB UK anticipate achieving the UK Approved Body designation from the MHRA during Q3/2023. Each accreditation has a defined scope and is site-specific. Intertek Capacity. Relevant resources at AMTAC will also transfer to report into Semko, but remain at current locations. For more information on Intertek's SWEDAC accreditation and Notified Body, please visit our intertek. Intertek Medical Notified Body now can start the process of taking on applications for MDR certification. Intertek is a Notified Body for the Gas Appliance Regulation (GAR) and Boiler Efficiency Directive (BED), accredited by the United Kingdom Accreditation Service (UKAS). (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. CE Marking The CE mark on your product indicates that the requirements of all necessary Directives have been met prior to it entering the EU. ) ECASEx program via application to/by Intertek’s network of Ex laboratories and Ex *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. Approved Body: Intertek Medical Notified Body UK Ltd 8532 Legislation: Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Hong Kong imnb@intertek. Intertek Testing Services Hong Kong Ltd Address. 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's ATEX Certification Solutions. At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. Industries Industries & Services Aug 29, 2023 · TÜV SÜD and Intertek have been designated as UK Approved Bodies to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. May 4, 2016 · 04 May 2016. Accreditations, Affiliations and Recognitions: Accreditations for Americas Accreditations for Asia Pacific May 3, 2016 · 03 May 2016. Aug 2, 2018 · Intertek is proud to be one of the first ISO 45001 UKAS accredited Certification Bodies. , enabling localized certification services for clients manufacturing equipment for explosive atmospheres in the European Union. 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. Ltd, and M/s TUV Sud South Asia Pvt. Our UK laboratory is accredited for the latest Gas Appliances Regulation EN298. Reference: Medical Devices The body is formally accredited against: EN ISO/IEC 17021 - Certification of management systems Name of National Accreditation Body (NAB): UKAS - United Kingdom May 3, 2016 · 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 Feb 14, 2020 · February 14, 2020. bola xaa hiuj qopf mfiwv zjvlx jjv kgbsot fgrlm amtzb