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MDR: Declaration of Conformity (DoC) template for medical devices
80,00€ excl. VAT -
Practical guidance on UDI requirements: examples and terms
50,00€ excl. VAT -
Webinar: IVD Market Authorisation EU vs. Canada – A Notified Body Perspective
20,00€ excl. VAT -
Webinar: Ensuring FDA Compliance for Medical Devices and Cosmetics
20,00€ excl. VAT -
Webinar: IVDR Legacy Extension & EUDAMED gradual roll-out
20,00€ excl. VAT -
Webinar: Step by Step MHRA Registration & Clinical Testing
20,00€ excl. VAT -
Webinar: MDCG Guidance on Authorised Representative
20,00€ excl. VAT -
Webinar: (New) MDR Legacy extension: EU, UK and CH
20,00€ excl. VAT -
IVDR: Deadlines
45,00€ excl. VAT -
MDR Extension – Self declaration (up-classified devices)
80,00€ excl. VAT -
MDR Extension – Self declaration (Custom Made)
80,00€ excl. VAT -
MDR Extension – Self declaration (Certificate expired before 20.03.2023)
80,00€ excl. VAT -
MDR Extension – Self declaration (Certificate expired after 20.03.23)
80,00€ excl. VAT -
PRRC Job Description – MDR
80,00€ excl. VAT -
PRRC Job Description – IVDR
80,00€ excl. VAT -
EU MDR Gap Assessment tool
325,00€ excl. VAT -
PRRC Designation Letter – IVDR
50,00€ excl. VAT -
IVDR Regulatory Strategy: Implementation guide
230,00€ excl. VAT -
MDR Regulatory Strategy: implementation guide
230,00€ excl. VAT -
MDR Compliance Roadmap
50,00€ excl. VAT -
Legacy devices: Clinical evaluation under MDR
230,00€ excl. VAT -
MDR Delay explained
80,00€ excl. VAT -
IVDR Technical Documentation Structure
230,00€ excl. VAT -
UDI under MDR/IVDR
230,00€ excl. VAT -
UDI, PRRC, PMS…all clarified!
45,00€ excl. VAT -
PRRC Designation Letter – MDR
50,00€ excl. VAT -
IVDR Distributor/Importer/Manufacturer Quality Agreement
500,00€ excl. VAT -
Medical Device Regulation 2017/745 Clinical Evaluation Report: Generalities
325,00€ excl. VAT -
MDD & MDR Comparison: Essential Safety and Performance Requirements
325,00€ excl. VAT -
MDR Distributor/Importer/Manufacturer Quality Agreement
500,00€ excl. VAT -
MDR Clinical Evaluation Plan
500,00€ excl. VAT -
MDR Checklist Labelling & IFU Requirements
500,00€ excl. VAT -
MDR e-Book: How will the new Regulation impact your business?
230,00€ excl. VAT -
IVDD & IVDR Comparison: Essential Safety and Performance Requirements
325,00€ excl. VAT -
IVDR: Strategic Recommendations for Manufacturers
80,00€ excl. VAT -
Guidance to compliance with IVDR (29 steps)
80,00€ excl. VAT -
Post-market surveillance requirements: Guidance to Manufacturers
330,00€ excl. VAT -
MDR Technical Documentation Guidance
160,00€ excl. VAT -
MDR Checklist: General Safety and Performance Requirements (Annex I)
500,00€ excl. VAT -
Understanding transitional period in MDR
80,00€ excl. VAT -
Guidance to compliance with MDR through 33 steps
80,00€ excl. VAT -
MDR: Deadlines
45,00€ excl. VAT -
IVDR e-Book
230,00€ excl. VAT -
108 Questions & Answers on MDR
250,00€ excl. VAT
