Regulatory Knowledge At A Glance U.S. Basics The IVD Product Types: RUO, IUO, GPR, ASR 31 January 2022 The Investigational Device Exemption (IDE) 28 January 2021 Three Essential Steps to Getting a Device to the U.S. Market 13 May 2020 The Safety and Performance Based Pathway 31 December 2019 Democratizing MedTech Regulatory Knowledge #regulatoryandmore The Shop Share Facebook Twitter Linkedin Whatsapp Envelope Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0) $50.00 Add to cart Checklist – ISO 13485 2016 Internal Audit (v.1.0) $50.00 Add to cart Template – SOP Master Validation Test Plan (v.1.0) $50.00 Add to cart Template – Technical Documentation Table of Content according to the IVDR (v1.0) $50.00 Add to cart Template – SOP Technical Documentation according the IVDR (v1.0) $50.00 Add to cart Follow Us Linkedin Twitter Facebook Instagram