ISO 13485 Certification

Certified on 30 November 2021, and valid untill 30 November 2024

SMART Clinical Products BV, has been certified by DNV Product Assurance AS – Veritasveien 3, 1363 Høvik, Norway for ISO 13485:2016 in accordance with the new Regulation 2017/745 of the European Parliament of the Council of 5 April 2017, concerning medical devices.

• 10000377188-PA-NA-SVK.pdf (87K)

EU Declaration of Conformity

15 November 2021

SMART Clinical Products has been certified by DNV Product Assurance AS – Veritasveien 3, 1363 Høvik, Norway , as one of the first companies in the EU, for our iD-Paddle™, a Class III Medical device,  a certificate under the Regulation 2017/745 of the European Parliament of the Council of 5 April 2017.