Intertek notified body. Elevenborgsvägen 2, 230 53 Alnarp .
Intertek notified body With 30 years of extensive experience in the industry, we pride ourselves on being a trusted partner for countless medical device manufacturers. r. 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 INTERTEK Italia S. The Machinery Directive also contains requirements for risk analysis. p. Via Fratelli Gracchi 2720092 Cinisello Balsamo (MI)Country : Italy Notified Body number : 2577 May 3, 2016 · 03 May 2016. The headquarters for IMNB AB is in Stockholm, Sweden. At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards. ** 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. Download our brief to learn more about auditing and certification services. Our product directories allow you to easily verify products that carry our marks. Via Guido Miglioli 2/A20063 Cernusco sul Naviglio - Milano (MI)Country : Italy Notified Body number : 2575 CE 2577 DEKRA Testing and Certification S. Intertek is a leading provider of comprehensive quality assurance services. Intertek’s UK Notified Body, AMTAC (NB No 0473), will be gradually phased out and eventually closed by 1 July 2018. 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) ErP Directive (2009/125/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). May 3, 2016 · 03 May 2016. Relevant resources at AMTAC will also transfer to report into Semko, but remain at current locations. Receiving the UKAS accreditation is a major milestone and a pre-requisite for designation as a UK Approved Body. The scope of our accreditation can be found here on the UKAS website: Intertek Medical Notified Body UK Limited. 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. Phone: +46 40 69 Scope: Notified Body to LVD, EMC, R&TTE, Machinery Directive ; Criteria: ISO/IEC 17025; SWEDAC - SE. He has more than 20 years of experience evaluating medical devices, performing quality registration audits, and conducting technical documentation 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 Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body Please complete the form below and submit to enter your pre-application for MDR 2017/745 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. com 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. , where our Notified Body number NB 0413 is located for MDD. 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. Intertek Medical Notified Body (IMNB) supports you along your compliance journey with a long history of excellence and expertise. 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. Timeliness is crucial, so ensure that your Notified Body is equipped to support the full applicable scope of your devices within the required period. May 4, 2016 · 04 May 2016. 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. Apr 2, 2019 · Triple Notified Body status for Intertek Italia. Nov 19, 2024 · Curtis Riley leads the Intertek Medical Notified Body’s regulatory compliance, quality assurance, and conformity assessments, ensuring that medical devices meet EU safety and performance standards. See full list on intertek. MDCG 2019-14 document To market your product in the EU, you must verify compliance to the Personal Protective Equipment Directive and obtain an assessment by a Notified Body, like Intertek. For more information on Intertek's SWEDAC accreditation and Notified Body, please visit our intertek. Email: IMNB@intertek. 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. Explore our broad array of capabilities and how our team of experts has become a trusted resource for the global medical This product certification body is accredited in accordance with the recognized International Standard ISO/IEC 17065:2012 Requirements for bodies certifying products, processes and services. . Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Elevenborgsvägen 2, 230 53 Alnarp . 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. We combine comprehensive internal capacity, direct contact with your file assessors, as well as the ability to combine audits and certifications. Intertek Medical Notified Body. *Intertek does not provide consulting services for management systems certification. Intertek has five European Union-based Notified Bodies located across Germany, Sweden, France, Spain and the United Kingdom. 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). com (Intertek Medical Notified Body) Division: Regulatory Services. 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 May 15, 2020 · 15 May 2020 MDR is a new set of regulations for the manufacturing of medical devices in the EU. Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. 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. se Swedish website. Medical Device News. Feb 24, 2020 · 24 Feb 2020. imnb@intertek. Intertek ScanBi Diagnostics. S. , enabling localized certification services for clients manufacturing equipment for explosive atmospheres in the European Union. Nov 14, 2024 · INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532) Academy Place 1-9 Brook Street Brentwood Essex CM14 5NQ Contact: Sharmila Gardner. Tel : 01277 321234 / 07875 633460. Jun 9, 2023 · Intertek Medical Notified Body UK Ltd (IMNB UK) is very pleased to announce we are now UKAS accredited for ISO 13485. Mar 28, 2024 · Notified Body Certification: Verify the readiness of your Notified Body to provide MDR certification. Testing. l. A. Treestand and Harness Testing Meet the Treestand Manufacturer’s Association (TMA) performance requirements and ensure the quality of your equipment with third-party testing. This product certification body also meets the A2LA R308 - Specific Requirements - ISO-IEC 17065 - Telecommunication Certification Body Accreditation. com. 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. Frequently Asked Questions: Intertek Medical Notified Body (IMNB) is designated under Medical Device Regulation (MDR) 2017/745. Feb 15, 2018 · Intertek will transition its European Notified Body Medical activities to Intertek Semko AB (NB No 0413) in Kista, Sweden. tulxxo zll irreaz rrnor stvcg dfo zfwny togmw qzcf xtigasv