Testing and Certification for Electrical Safety and Electromagnetic Compatability (EMC)
To bring your medical device to North American, European and global markets with speed and efficiency, you need a testing and certification partner who knows your business. Count on tuvpak for compliance testing and certification to harmonized global standards and requirements, all from a single source.
IEC 60601-1 Medical Electrical Equipment Standard
Your new and existing medical devices must demonstrate compliance with the latest revision of IEC 60601-1. Navigate the new requirements of the Amendments to the 3rd Edition with tuvpak and reach your target markets.
IEC 60601-1-2 Electromagnetic Compatibility
Access the world’s largest network of EMC laboratories and discover our complete testing solutions per IEC 60601-1-2 and EMC Directive specifications for your medical device.
CB Scheme Testing and Certification
Learn how you can obtain multiple national safety certifications for your product and gain entry to more than 50 countries through the IECEE’s International program. Globally, tuvpak has an industry-leading accreditation scope for CB Scheme across our Medical Center’s of Excellence.
FDA ACSA Pilot Program
Simplify your FDA submittals while shortening your time to market with participation in the FDA’s ASCA Pilot Program utilizing tuvpak’s 13 ASCA Accredited Medical Testing Labs.
EU Medical Devices Regulation (MDR 2017/745)
Before you can market your medical device in the EU, your product must meet the essential requirements of the MDR and bear the CE Mark.
In Vitro Diagnostic Directive 98/79/EC
Give your in vitro diagnostic device a head-start to achieving EU market access. We can help you address essential requirements of the IVDD and prepare your Declaration of Conformity.
EU RoHS 2 Recast Directive Services
Our global expert network provides you a single-source solution for RoHS compliance, including technical documentation, BoM assessment, testing, consulting, and product certification.
*The tuvpak 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. Clients who have used other tuvpak legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from tuvpak.
