If you want to place your medical device on the market, you need to comply with the relevant national and international standards. Delaying certification can mean lost time and missed opportunities.
Speed up your certification with SGS
Most Conformity Assessment Bodies are overwhelmed and capacity-constrained. We can help you get your application in the queue and certified faster.
SS 620/GDPMDS certification
SS 620/GDPMDS certification demonstrates compliance with Singapore’s Good Distribution Practice requirements for medical devices throughout storage, transportation and distribution. It is required for all companies that import, transport, distribute or store medical devices and in vitro medical devices (IVDs) in Singapore. We will support your SS 620/GDPMDS certification journey from application through certification.
ISO 13485 (Medical devices – Quality management systems) certification
ISO 13485 is the internationally recognized quality management system standard for medical device manufacturers. It supports compliance with global medical device regulations and is often the foundation for MDR, IVDR and MDSAP certification. We offer global expertise and a team of experienced auditors to help you achieve and maintain ISO 13485 certification.
Medical Device Single Audit Program (MDSAP) services
MDSAP allows medical device manufacturers to comply with the audit requirements of all MSDAP countries by undergoing just one audit. As an Auditing Organization (AO), we will help you meet the requirements of the medical device regulatory authorities of Australia, Brazil, Canada, the US and Japan.
EU Medical Device Regulation (MDR) certification
The MDR replaces the EU’s previous Medical Device Directive (MDD) and introduces significantly stricter requirements for manufacturers wanting to access the EU market. All medical devices certified under the MDD must certify to the new MDR to continue being sold on the EU market. As a Notified Body, we support manufacturers throughout the EU MDR certification journey.
EU In Vitro Diagnostic Medical Device Regulation (IVDR) certification
IVDR certification allows you to place your in vitro diagnostic device on the EU market. We provide IVDR certification services, conformity assessments and documentation reviews to help you achieve regulatory compliance and accelerate market access.
Why SGS?
As a world leader in assessment, auditing and certification, we provide comprehensive support to help you ensure compliance with diverse national standards for medical devices. Our experts have the regulatory expertise and technical knowledge to help you navigate complex standards and requirements and get your products to market.