About SGS North America Inc.

SGS helps bring medical devices to market safely and efficiently. Whether it's certifying an organization's processes to ISO 13485, transitioning devices from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) or facilitating market placement with MDSAP, UKCA and CE marking, SGS brings the expertise and experience to meet the rigorous requirements of the medical device industry and its regulators.

As a full-solution provider, we help medical device clients ensure their products are of highest and consistent quality, while meeting the regulatory requirements for their intended purpose. We are one of the few organizations that can offer medical device CE marking as a Notified Body through our affiliate in Belgium (1639), and in Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD) products. SGS is also a UK Approved Body (0120) able to provide conformity assessments under the UKCA scheme for Great Britain. 

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201 Route 17 North 7th Floor Rutherford, NJ 07070

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