Claims under the MDR and the IVDR (Art. 7/7) 10 January 202220 January 2022 Conformity Assessment Options for Products Failing under the MDR 18 January 202120 January 2022 Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements 7 January 202120 January 2022 Trend Reporting under the MDR and IVDR (Art. 88/83) 12 November 202020 January 2022 Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR (Art. 95/90) 4 November 202020 January 2022 Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89) 4 November 202020 January 2022 The Periodic Safety Update Report (PSUR) under the MDR and the IVDR (Art. 86/81) 30 October 202020 January 2022 The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15) 28 October 202020 January 2022 The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8)) 19 October 202020 January 2022 The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79) 6 October 202020 January 2022 The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55) 15 September 202020 January 2022 The EU Declaration of Conformity (DoC) under the MDR and the IVDR (Art. 19/17) 27 August 202020 January 2022 The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) 18 August 202020 January 2022 The Clinical Evidences: Definitions and Elements under the IVDR 15 April 202020 January 2022 Linguistic Requirements under the MDR and the IVDR 25 February 20206 October 2020 EU’s Governmental Bodies 26 January 202020 January 2022 Medical Device CE Marking 4 January 202020 January 2022 MD vs IVD 3 January 202020 January 2022 The Technical Documentation under the IVDR 3 January 202020 January 2022 How to Complete the Essential Principles (EP) Checklist 2 January 202020 January 2022 The New European Medical Device Regulation and In Vitro Diagnostic Device Regulation 1 January 202020 January 2022 Process of Conformity and CE Marking: Key entities 1 January 202020 January 2022 European Directives and Regulations 7 October 201920 January 2022 7 Key Elements of a CE Technical File under the IVDR 6 February 201920 January 2022 Regulatory Knowledge At A Glance EU Basics Claims under the MDR and the IVDR (Art. 7/7) 10 January 2022 Conformity Assessment Options for Products Failing under the MDR 18 January 2021 Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements 7 January 2021 Trend Reporting under the MDR and IVDR (Art. 88/83) 12 November 2020 Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR (Art. 95/90) 4 November 2020 Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89) 4 November 2020 The Periodic Safety Update Report (PSUR) under the MDR and the IVDR (Art. 86/81) 30 October 2020 The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15) 28 October 2020 The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8)) 19 October 2020 The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79) 6 October 2020 The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55) 15 September 2020 The EU Declaration of Conformity (DoC) under the MDR and the IVDR (Art. 19/17) 27 August 2020 The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) 18 August 2020 The Clinical Evidences: Definitions and Elements under the IVDR 15 April 2020 Linguistic Requirements under the MDR and the IVDR 25 February 2020 EU’s Governmental Bodies 26 January 2020 Medical Device CE Marking 4 January 2020 MD vs IVD 3 January 2020 The Technical Documentation under the IVDR 3 January 2020 How to Complete the Essential Principles (EP) Checklist 2 January 2020 The New European Medical Device Regulation and In Vitro Diagnostic Device Regulation 1 January 2020 Process of Conformity and CE Marking: Key entities 1 January 2020 European Directives and Regulations 7 October 2019 7 Key Elements of a CE Technical File under the IVDR 6 February 2019 Democratizing MedTech Regulatory Knowledge #regulatoryandmore The Shop Share Facebook Twitter Linkedin Whatsapp Envelope View cart “Template – SOP Technical Documentation according the IVDR (v1.0)” has been added to your cart. 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Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements 7 January 202120 January 2022
Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR (Art. 95/90) 4 November 202020 January 2022
Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89) 4 November 202020 January 2022
The Periodic Safety Update Report (PSUR) under the MDR and the IVDR (Art. 86/81) 30 October 202020 January 2022
The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15) 28 October 202020 January 2022
The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8)) 19 October 202020 January 2022
The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79) 6 October 202020 January 2022
The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55) 15 September 202020 January 2022
The EU Declaration of Conformity (DoC) under the MDR and the IVDR (Art. 19/17) 27 August 202020 January 2022
The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) 18 August 202020 January 2022
The New European Medical Device Regulation and In Vitro Diagnostic Device Regulation 1 January 202020 January 2022
Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements 7 January 2021
Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR (Art. 95/90) 4 November 2020
Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89) 4 November 2020
The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15) 28 October 2020
The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) 18 August 2020