Regulatory Knowledge at a Glance Regulatory Management Library VisualMaker “An investment in knowledge always pays the best interest.” Benjamin Franklin 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 The IVD Product Types: RUO, IUO, GPR, ASR Read More » Claims under the MDR and the IVDR (Art. 7/7) Read More » The Investigational Device Exemption (IDE) Read More » Conformity Assessment Options for Products Failing under the MDR Read More » Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements Read More » Trend Reporting under the MDR and IVDR (Art. 88/83) Read More » Follow Us Linkedin Twitter Facebook Instagram Click to share on LinkedIn (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on Facebook (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to email this to a friend (Opens in new window)
Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements Read More »