Medical Device Certification Services

As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before you can sell your devices on the international market.

STEMart provides comprehensive certification services to help medical device and IVD companies with regulatory compliance and market entry.

Medical Device Certification Services

FDA Approval >

STEMart provides cost-effective approach to assist medical device manufacturers in receiving FDA clearance of a 510(k) submission.

STEMart provides medical device manufacturers with superior Notified Body Service according to the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC to assist them earn a CE marking.

NRTL & SCC (US & CAN) >

STEMart provides medical device manufacturers with testing and certification of electrical & electronic (EE) products under NRTL and SCC program to demonstrate that the electrical and mechanical safety of their product complies with the currently applicable safety requirements for the US and Canada.

CB Scheme >

STEMart offers comprehensive testing for safety, electromagnetic compatibility and energy efficiency of electrical and electronic equipment, devices and components to help manufacturer obtain a national safety certification for their products in the markets of more than 50 participating countries.

INMETRO Certification >

Medical devices with electrical components and some non-electric devices must be certified by INMETRO in order to obtain National Health Surveillance Agency (ANVISA) registration in Brazil. STEMart all the necessary services for INMETRO compliance to help manufacturer apply the INMETRO seal of approval on their products.

ISO 13485 Audits >

ISO 13485:2016 is the internationally recognized quality management system suitable for the design and development, production, installation and service of medical device as well as related services in the design, development and provision of related industries. SETMart provides a ISO 13485 audit for medical device manufacturer to help them gain access to global markets.

Medical Devices Single Audit Program (US, AUS, BR, CAN & JPN) >

SETMart provides a single MDSAP audit for medical device manufacturer to help them gain access to multiple markets, reducing the number of audits and inspections, minimising business disruptions and reducing costs.

NMPA Registration >

STEMart helps medical device manufacturers with NMPA registration to successfully introduce your products to the Chinese market.

STEMart provides regulatory strategy, inspection, quality management system compliance, device registration services for the medical industry. Our unique combination of in-depth knowledge and global presence has brought confidence and peace of mind to thousands of organizations all over the world. If you want to learn more detail about our medical device certification services, or would like to consult with the experts at STEMart, please feel free to contact us.

Medical Device Certification Services