Avada Accountant Demo

Technical Documentation for MDR and IVDR – Preparation, updating, and content control

This course offers a practical approach to the preparation and updating of technical documentation, using operational checklists and real-life case studies.

This course belongs to the “Regulatory core” line: Core regulatory expertise in the MD field.

Contact our team if you would like a complete training package covering all related topics, or to request a tailored solution.

Abstract

This course offers a practical approach to the preparation and updating of technical documentation, using operational checklists and real-life case studies. It is designed to support companies in maintaining compliance throughout the entire device lifecycle.

Key Points

  • MDR/IVDR technical documentation

  • Content control via operational checklists

  • Application through real-life case studies

  • Compliance across device lifecycle

Structure

8-hour course.

Live streaming or on-site at your company, based on your needs.

 

Would you like to host this course at your company?

Contact Us

    Email*

    First Name*

    Last Name*

    Company*

    Country*

    Your Notes*

    I have read and understood the Privacy policy and I would like to subscribe to the Complife newsletter to receive company updates, promotional content, and information about training events.

    You may be interested also in

    MDR (EU) 2017/745 – Operational Management of Regulatory Obligations

    Medical Devices

    8 hours

    MDR (EU) 2017/745 – Operational Management of Regulatory Obligations

    This course addresses the practical management of regulatory obligations under the MDR, with a focus on responsibilities, document flows, and the required checks throughout the supply chain.

    IVDR (Reg. UE 2017/746): Implementation and Gap Analysis

    Medical Devices

    8 hours

    IVDR (Reg. UE 2017/746): Implementation and Gap Analysis

    This course focuses on the practical application of the IVDR, analyzing key requirements and the main differences compared to the previous framework.

    PRRC – Integration of the role into company processes

    Medical Devices

    8 hours

    PRRC – Integration of the role into company processes

    This course examines how to effectively integrate the PRRC role into company quality and regulatory processes.

    Technical Documentation for MDR and IVDR – Preparation, updating, and content control

    Medical Devices

    8 hours

    Technical Documentation for MDR and IVDR – Preparation, updating, and content control

    This course offers a practical approach to the preparation and updating of technical documentation, using operational checklists and real-life case studies.

    UDI/EUDAMED: Processes, modules, and practical requirements

    Medical Devices

    8 hours

    UDI/EUDAMED: Processes, modules, and practical requirements

    This course is dedicated to the practical management of UDI requirements and the use of EUDAMED, with a focus on processes, modules, and information flows required by the MDR.

    Cybersecurity for Medical Devices (including Software and IVDs)

    Medical Devices

    8 hours

    Cybersecurity for Medical Devices (including Software and IVDs)

    This course explains how to address and prevent the main cyber threats affecting medical devices and medical software, analyzing European regulatory requirements and international regulatory expectations.

    AI Act & Software as a Medical Device: Compliance, Assessment, and Strategies

    Medical Devices

    8 hours

    AI Act & Software as a Medical Device: Compliance, Assessment, and Strategies

    This course examines the impact of the AI Act in the field of medical devices, with a focus on the interactions between MDR, GDPR, and the AI Act.

    ISO 13485 Quality Systems Audit – Methodology and operational practice according to ISO 13485

    Medical Devices

    8 hours

    ISO 13485 Quality Systems Audit – Methodology and operational practice according to ISO 13485

    This course provides a structured and practical overview of the internal audit process for medical device quality systems, in accordance with ISO 13485 and ISO 19011.

    ISO 13485:2016 – Operational management of the quality system

    Medical Devices

    8 hours

    ISO 13485:2016 – Operational management of the quality system

    This course provides a practical interpretation of ISO 13485 requirements applied to the daily management of the Quality System.

    Change control, CAPA, and non-conformity management

    Medical Devices

    8 hours

    Change control, CAPA, and non-conformity management

    This course provides an in-depth overview of the structured management of changes, non-conformities, and CAPAs as key elements of the Quality System.

    Supply Chain & Suppliers: Audits, QTA, and regulatory responsibilities

    Medical Devices

    8 hours

    Supply Chain & Suppliers: Audits, QTA, and regulatory responsibilities

    This course focuses on supplier management in the Medical Device sector, with emphasis on audits, Quality Technical Agreements (QTA), and regulatory responsibilities across the supply chain.

    Cleanrooms: Maintenance, calibration, and validation

    Medical Devices

    8 hours

    Cleanrooms: Maintenance, calibration, and validation

    This course provides a practical approach to cleanroom management, with particular focus on maintenance, calibration, and validation activities.

    FDA QSR & cGMP (21 CFR 820): How to prepare for a US Audit

    Medical Devices

    4 hours

    FDA QSR & cGMP (21 CFR 820): How to prepare for a US Audit

    This course provides a practical guide to FDA requirements applicable to medical devices, focusing on the Quality System Regulation (QSR) and cGMP.

    Brazil Compliance RDC 665/2022 – ANVISA

    Medical Devices

    4 hours

    Brazil Compliance RDC 665/2022 – ANVISA

    This course provides an in-depth overview of ANVISA regulatory requirements for accessing the Brazilian market, with particular focus on the required documentation and audit expectations.

    MDSAP: What It Is and how to successfully prepare for an MDSAP Audit

    Medical Devices

    4 hours

    MDSAP: What It Is and how to successfully prepare for an MDSAP Audit

    This course examines the MDSAP program as a key tool for achieving simultaneous compliance across participating international markets.

    UDI System – Step-by-step operational guide (Europe, USA, Brazil)

    Medical Devices

    4 hours

    UDI System – Step-by-step operational guide (Europe, USA, Brazil)

    This course provides a step-by-step guide to implementing the UDI system in major markets (EU, USA, and Brazil), clarifying requirements, differences, and impacts on company processes.

    USA / FDA – Fundamentals of export compliance for MD

    Medical Devices

    4 hours

    USA / FDA – Fundamentals of export compliance for MD

    This course provides an essential overview of FDA requirements for accessing the US market, focusing on roles, responsibilities, and basic obligations needed to navigate the certification process and obtain marketing authorization for medical devices.

    Canada – Fundamentals of export compliance for Medical Devices

    Medical Devices

    4 hours

    Canada – Fundamentals of export compliance for Medical Devices

    This course introduces the key regulatory requirements for placing medical devices on the Canadian market, focusing on the role of Health Canada and the basic obligations necessary to navigate the registration process.

    Design Control according to ISO 13485/MDSAP: Robust and Audit-ready design

    Medical Devices

    8 hours

    Design Control according to ISO 13485/MDSAP: Robust and Audit-ready design

    This course provides an in-depth overview of Design Control applied to medical devices according to ISO 13485 and MDSAP requirements, focusing on structured design, traceability, and impact on technical documentation.

    Medical Software: Management and validation according to ISO/TR 80002-2

    Medical Devices

    8 hours

    Medical Software: Management and validation according to ISO/TR 80002-2

    This course is dedicated to the management and validation of medical software in accordance with ISO/TR 80002-2, focusing on risks, required controls, and audit expectations.

    Sterile Packaging: Validation according to ISO 11607 and GMP

    Medical Devices

    8 hours

    Sterile Packaging: Validation according to ISO 11607 and GMP

    This course addresses the validation of sterile packaging according to ISO 11607-1/2 and GMP requirements, analyzing approaches, testing methods, and the most common critical issues.

    Sterilization Process and Its validation up to the Sterile Barrier

    Medical Devices

    8 hours

    Sterilization Process and Its validation up to the Sterile Barrier

    This course provides a comprehensive analysis of the sterilization process, from parameter definition to sterile barrier validation.

    Sterilization: Steam and Ionizing radiation

    Medical Devices

    8 hours

    Sterilization: Steam and Ionizing radiation

    This course provides an in-depth overview of the main sterilization methods using steam and ionizing radiation, focusing on regulatory requirements, process controls, and validation activities.

    Usability of Medical Devices – Requirements and practical application

    Medical Devices

    8 hours

    Usability of Medical Devices – Requirements and practical application

    This course explores the principles of Human Factors Engineering applied to medical devices, focusing on usability requirements and their integration into technical documentation.

    IEC 60601‑1 – Safety of electromedical devices and conformity testing

    Medical Devices

    8 hours

    IEC 60601‑1 – Safety of electromedical devices and conformity testing

    This course is dedicated to the safety requirements, essential performance, and electromagnetic compatibility of medical electrical equipment and systems within the scope of EN 60601-1.

    Post-Market Surveillance (PMS): Organization, Best Practices, and incident reporting

    Medical Devices

    8 hours

    Post-Market Surveillance (PMS): Organization, Best Practices, and incident reporting

    This course provides a practical guide to organizing a Post-Market Surveillance system in accordance with the MDR, focusing on roles, information flows, and best practices.

    Complaint Management, Regulatory reporting, and vigilance

    Medical Devices

    8 hours

    Complaint Management, Regulatory reporting, and vigilance

    This course provides an in-depth overview of complaint management and vigilance reporting, analyzing regulatory requirements, timelines, and responsibilities, with a focus on MDR (EU) 2017/745 and IVDR (EU) 2017/746.

    ISO 18969 – Clinical Evaluation and Post-Market clinical follow-up (PMCF)

    Medical Devices

    8 hours

    ISO 18969 – Clinical Evaluation and Post-Market clinical follow-up (PMCF)

    This course provides an in-depth overview of ISO 18969 requirements for the planning and management of Clinical Evaluation activities in accordance with the MDR.

    Microplastics: Definitions, restrictions, and new notifications

    Cosmetics

    4 hours

    Microplastics: Definitions, restrictions, and new notifications

    A technical analysis of Regulation 2023/2055 to understand the definition of microplastics and the associated reporting and notification obligations.

    Sunscreens: Formulation, testing strategies, and regulatory context

    Cosmetics

    8 hours

    Sunscreens: Formulation, testing strategies, and regulatory context

    This course provides a comprehensive overview of sun protection, analyzing the impact of UVA/UVB radiation and the biological mechanisms of photoprotection.

    Skin Microbiome: The invisible ecosystem of the skin

    Cosmetics

    4 hours

    Skin Microbiome: The invisible ecosystem of the skin

    Discover how microbiome balance influences skin health, based on the latest evidence from the Complife university research team.

    Global Regulatory: The international regulatory landscape of the cosmetic market

    Cosmetics

    4 hours

    Global Regulatory: The international regulatory landscape of the cosmetic market

    An analysis of the technical and legislative requirements necessary for placing cosmetic products on the market in the EU, UK, USA, Canada, and China.

    California Proposition 65: Compliance obligations for cosmetic products

    Cosmetics

    4 hours

    California Proposition 65: Compliance obligations for cosmetic products

    A technical analysis of Proposition 65, with particular focus on the criteria for determining the presence of substances exceeding the safe harbor limits.

    Regulatory framework for fragrances and perfume ingredients: IFRA standards, allergens, and safety assessment

    Cosmetics

    4 hours

    Regulatory framework for fragrances and perfume ingredients: IFRA standards, allergens, and safety assessment

    An advanced technical analysis of the regulatory framework for fragrances and perfume ingredients, with a focus on IFRA standards, ingredient restrictions, and allergens.

    Cosmetovigilance: Adverse event management and compliance

    Cosmetics

    4 hours

    Cosmetovigilance: Adverse event management and compliance

    From regulatory foundations to procedural obligations under EU, UK, and US regulations, with a focus on implementing an effective quality system for managing adverse events and serious undesirable effects.

    Testing and Marketing: Synergies in building the evidential support

    Cosmetics

    4 hours

    Testing and Marketing: Synergies in building the evidential support

    Translating a technical report into marketing concepts is a key step in transforming experimental data, regulatory constraints, and scientific rationale into clear, credible, and market-ready value messages.

    PPWR Regulation: The future of sustainable packaging

    Cosmetics

    6 hours

    PPWR Regulation: The future of sustainable packaging

    This course provides a clear overview of Regulation (EU) 2025/40 (PPWR) on packaging and packaging waste, which introduces harmonized rules at the European level.

    Beauty Claims & In-Out: Between cosmetics and nutraceuticals

    Nutraceuticals

    4 hours

    Beauty Claims & In-Out: Between cosmetics and nutraceuticals

    This course explores the “In & Out” approach as an integrated strategy between cosmetics and dietary supplementation, with particular focus on Beauty Claims.

    Novel Food: Regulatory framework and testing strategies

    Nutraceuticals

    4 hours

    Novel Food: Regulatory framework and testing strategies

    This course provides an operational overview of the European regulatory framework for Novel Foods, with a focus on testing strategies supporting safety assessment.

    MDR (EU) 2017/745 – Practical Management of Regulatory Obligations

    MDR (EU) 2017/745 – Practical Management of Regulatory Obligations

    a practical approach to managing the regulatory obligations required by the MDR

    Committed to Science.
    Committed to you.

    Markets

    Cosmetics

    Nutraceuticals

    Medical Devices

    Pharma

    Latest News

    The Group

    Company Information

    © Copyright 2017 - 2026 | All rights reserved - Complife Group | Whistleblowing
    VAT No. IT11093320155 Share Capital: €500 000 i.v.
    Impressum | Privacy | Cookies Policy | Website designed by Studio Verdi22.

    Back to top