SGS NORTH AMERICA

SGS NORTH AMERICA

SA
Company Profile

SGS NORTH AMERICA

Bloomfield | Fairfiled | Farmingdale | Richardson | Rutherford | Suwanee, United States of America

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Overview

Company details and contact information.

About

About SGS NORTH AMERICA About SGS North America Inc. The world’s leading testing, inspection and certification company. We are SGS, recognized as the global benchmark for sustainability, quality and integrity. Our 99,000 employees operate a network of more than 2,600 offices and laboratories and work to enable a better, safer and more interconnected world. We are SGS – the world's leading testing, inspection and certification company. Our global connectivity services include wireless and electrical and electronics testing, inspection and certification to support compliance and market access. SGS provides comprehensive services to help medical device manufacturers bring safe, compliant, and high-quality products to market efficiently. As an EU Notified Body (1639) and UK Approved Body (0120), we deliver conformity assessments under IVDR, MDR, and the UKCA scheme, supporting global market access. Our expertise spans Software as a Medical Device (SaMD), in vitro diagnostics, active and implantable devices, PPE, and packaging. We also serve as an Auditing Organization (AO) for MDSAP certification. Through our global network of laboratories and technical experts, SGS offers testing, inspection, training, and certification services covering QMS audits, technical documentation assessments, extractables and leachables analysis, and container closure integrity testing. With SGS, manufacturers gain a trusted partner ensuring compliance with evolving regulations while maintaining product safety, performance, and reliability across international markets. At SGS, we help bring medical devices to market safely and efficiently. As a full-solution provider, we assist medical device clients in ensuring their products are of the highest and most consistent quality while meeting regulatory requirements for their intended purpose. We offer medical device CE marking as a Notified Body through our affiliates in Belgium (1639) and Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD) products. SGS is a UK Approved Body (0120) providing conformity assessments under the UKCA scheme for Great Britain and is an Auditing Organization (AO) for MDSAP certification. We provide training, assessment, testing, and certification through our network of more than 2,700 offices and laboratories worldwide. SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,700 laboratories and business facilities across 119 countries, supported by a team of 99,250 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, safety and compliance. Our brand promise, when you need to be sure, underscores our commitment to reliability, integrity and trust — enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource. SGS’s Connectivity & Products division provides the world’s most comprehensive range of inspection, testing, certification, and advisory services, powered by leading technology and digital tools. We are the trusted solution for the Electrical & Electronics Industry, ensuring our clients’ electrical and electronic products are safe, performant and energy efficient. SGS battery testing services can identify your target market regulations for cells, batteries and modules to ensure compliance with contractual or regulatory requirements. We can provide expert testing services for abuse, benchmarking, durability, electrical, electromagnetic compatibility (EMC), environmental, life cycle analysis, performance, safety standards and transportation on cells, batteries and modules. Our ISO/IEC 17025 accredited testing laboratories and specialized local experts have extensive experience with battery testing and offer a range of services to manufacturers and buyers in the industry. With unrivaled experience we can provide all the required technical verifications, safety settings and factory auditing services. SGS provides comprehensive services to help medical device manufacturers bring safe, compliant, and high-quality products to market efficiently. As an EU Notified Body (1639) and UK Approved Body (0120), we deliver conformity assessments under IVDR, MDR, and the UKCA scheme, supporting global market access. Our expertise spans Software as a Medical Device (SaMD), in vitro diagnostics, active and implantable devices, PPE, and packaging. We also serve as an Auditing Organization (AO) for MDSAP certification. Through our global network of laboratories and technical experts, SGS offers testing, inspection, training, and certification services covering QMS audits, technical documentation assessments, extractables and leachables analysis, and container closure integrity testing. With SGS, manufacturers gain a trusted partner ensuring compliance with evolving regulations while maintaining product safety, performance, and reliability across international markets. At SGS, we help bring medical devices to market safely and efficiently. As a full-solution provider, we assist medical device clients in ensuring their products are of the highest and most consistent quality while meeting regulatory requirements for their intended purpose. We offer medical device CE marking as a Notified Body through our affiliates in Belgium (1639) and Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD) products. SGS is a UK Approved Body (0120) providing conformity assessments under the UKCA scheme for Great Britain and is an Auditing Organization (AO) for MDSAP certification. We provide training, assessment, testing, and certification through our network of more than 2,700 offices and laboratories worldwide.

Address
Rutherford NJ | 1801 N. Glenville Drive, Richardson 75081, United States of America | 620 Old Peachtree Road, Suite 100, Suwanee GA 30024, United States of America | 400 Broadacres Dr, Ste 200, Bloomfield NJ 07003, United States of America | 400 Broadacres Drive, Suite 200, 2nd Floor, Bloomfield NJ 07003, United States of America | 291 Fairfield Ave, Fairfiled NJ 07004, United States of America | 201 Route 17 North, 7th & 8th Floors, Rutherford NJ 07070, United States of America | 201 Route 17 North, 7th floor, Rutherford NJ 07070, United States of America | 96 Allen Blvd, Farmingdale NY 11735, United States of America

People

Contacts connected to this company.

TM

Tomas Miko

Sales Director – Compass | Supply Chain Management Solutions

BB

Balazs Bozsik

Technical Director – Medical Audit, NAM

DF

Daniel Fisher

Regional Sales Manager - Med Devices