In-house Training

Our primary goal is to drive organizational evolution and strengthen the professional and personal skills of teams, enabling them to operate effectively in the industry.

Below is a selection of in-house courses we recommend.

We are ready to design ad-hoc training courses, and each proposal can be tailored to specific needs.

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

8 hours

MDR (EU) 2017/745 – Operational Management of Regulatory Obligations
Abstract
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.
Details
IVDR (Reg. UE 2017/746): Implementation and Gap Analysis
Medical Devices

8 hours

IVDR (Reg. UE 2017/746): Implementation and Gap Analysis
Abstract
This course focuses on the practical application of the IVDR, analyzing key requirements and the main differences compared to the previous framework.
Details
PRRC – Integration of the role into company processes
Medical Devices

8 hours

PRRC – Integration of the role into company processes
Abstract
This course examines how to effectively integrate the PRRC role into company quality and regulatory processes.
Details
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
Abstract
This course offers a practical approach to the preparation and updating of technical documentation, using operational checklists and real-life case studies.
Details
UDI/EUDAMED: Processes, modules, and practical requirements
Medical Devices

8 hours

UDI/EUDAMED: Processes, modules, and practical requirements
Abstract
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.
Details
Cybersecurity for Medical Devices (including Software and IVDs)
Medical Devices

8 hours

Cybersecurity for Medical Devices (including Software and IVDs)
Abstract
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.
Details
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
Abstract
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.
Details
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
Abstract
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.
Details
ISO 13485:2016 – Operational management of the quality system
Medical Devices

8 hours

ISO 13485:2016 – Operational management of the quality system
Abstract
This course provides a practical interpretation of ISO 13485 requirements applied to the daily management of the Quality System.
Details
Change control, CAPA, and non-conformity management
Medical Devices

8 hours

Change control, CAPA, and non-conformity management
Abstract
This course provides an in-depth overview of the structured management of changes, non-conformities, and CAPAs as key elements of the Quality System.
Details
Supply Chain & Suppliers: Audits, QTA, and regulatory responsibilities
Medical Devices

8 hours

Supply Chain & Suppliers: Audits, QTA, and regulatory responsibilities
Abstract
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.
Details
Cleanrooms: Maintenance, calibration, and validation
Medical Devices

8 hours

Cleanrooms: Maintenance, calibration, and validation
Abstract
This course provides a practical approach to cleanroom management, with particular focus on maintenance, calibration, and validation activities.
Details
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
Abstract
This course provides a practical guide to FDA requirements applicable to medical devices, focusing on the Quality System Regulation (QSR) and cGMP.
Details
Brazil Compliance RDC 665/2022 – ANVISA
Medical Devices

4 hours

Brazil Compliance RDC 665/2022 – ANVISA
Abstract
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.
Details
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
Abstract
This course examines the MDSAP program as a key tool for achieving simultaneous compliance across participating international markets.
Details
UDI System – Step-by-step operational guide (Europe, USA, Brazil)
Medical Devices

4 hours

UDI System – Step-by-step operational guide (Europe, USA, Brazil)
Abstract
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.
Details
USA / FDA – Fundamentals of export compliance for MD
Medical Devices

4 hours

USA / FDA – Fundamentals of export compliance for MD
Abstract
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.
Details
Canada – Fundamentals of export compliance for Medical Devices
Medical Devices

4 hours

Canada – Fundamentals of export compliance for Medical Devices
Abstract
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.
Details
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
Abstract
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.
Details
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
Abstract
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.
Details
Sterile Packaging: Validation according to ISO 11607 and GMP
Medical Devices

8 hours

Sterile Packaging: Validation according to ISO 11607 and GMP
Abstract
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.
Details
Sterilization Process and Its validation up to the Sterile Barrier
Medical Devices

8 hours

Sterilization Process and Its validation up to the Sterile Barrier
Abstract
This course provides a comprehensive analysis of the sterilization process, from parameter definition to sterile barrier validation.
Details
Sterilization: Steam and Ionizing radiation
Medical Devices

8 hours

Sterilization: Steam and Ionizing radiation
Abstract
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.
Details
Usability of Medical Devices – Requirements and practical application
Medical Devices

8 hours

Usability of Medical Devices – Requirements and practical application
Abstract
This course explores the principles of Human Factors Engineering applied to medical devices, focusing on usability requirements and their integration into technical documentation.
Details
IEC 60601‑1 – Safety of electromedical devices and conformity testing
Medical Devices

8 hours

IEC 60601‑1 – Safety of electromedical devices and conformity testing
Abstract
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.
Details
Post-Market Surveillance (PMS): Organization, Best Practices, and incident reporting
Medical Devices

8 hours

Post-Market Surveillance (PMS): Organization, Best Practices, and incident reporting
Abstract
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.
Details
Complaint Management, Regulatory reporting, and vigilance
Medical Devices

8 hours

Complaint Management, Regulatory reporting, and vigilance
Abstract
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.
Details
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)
Abstract
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.
Details
Microplastics: Definitions, restrictions, and new notifications
Cosmetics

4 hours

Microplastics: Definitions, restrictions, and new notifications
Abstract
A technical analysis of Regulation 2023/2055 to understand the definition of microplastics and the associated reporting and notification obligations.
Details
Sunscreens: Formulation, testing strategies, and regulatory context
Cosmetics

8 hours

Sunscreens: Formulation, testing strategies, and regulatory context
Abstract
This course provides a comprehensive overview of sun protection, analyzing the impact of UVA/UVB radiation and the biological mechanisms of photoprotection.
Details
Skin Microbiome: The invisible ecosystem of the skin
Cosmetics

4 hours

Skin Microbiome: The invisible ecosystem of the skin
Abstract
Discover how microbiome balance influences skin health, based on the latest evidence from the Complife university research team.
Details
Global Regulatory: The international regulatory landscape of the cosmetic market
Cosmetics

4 hours

Global Regulatory: The international regulatory landscape of the cosmetic market
Abstract
An analysis of the technical and legislative requirements necessary for placing cosmetic products on the market in the EU, UK, USA, Canada, and China.
Details
California Proposition 65: Compliance obligations for cosmetic products
Cosmetics

4 hours

California Proposition 65: Compliance obligations for cosmetic products
Abstract
A technical analysis of Proposition 65, with particular focus on the criteria for determining the presence of substances exceeding the safe harbor limits.
Details
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
Abstract
An advanced technical analysis of the regulatory framework for fragrances and perfume ingredients, with a focus on IFRA standards, ingredient restrictions, and allergens.
Details
Cosmetovigilance: Adverse event management and compliance
Cosmetics

4 hours

Cosmetovigilance: Adverse event management and compliance
Abstract
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.
Details
Testing and Marketing: Synergies in building the evidential support
Cosmetics

4 hours

Testing and Marketing: Synergies in building the evidential support
Abstract
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.
Details
PPWR Regulation: The future of sustainable packaging
Cosmetics

6 hours

PPWR Regulation: The future of sustainable packaging
Abstract
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.
Details
Beauty Claims & In-Out: Between cosmetics and nutraceuticals
Nutraceuticals

4 hours

Beauty Claims & In-Out: Between cosmetics and nutraceuticals
Abstract
This course explores the “In & Out” approach as an integrated strategy between cosmetics and dietary supplementation, with particular focus on Beauty Claims.
Details
Novel Food: Regulatory framework and testing strategies
Nutraceuticals

4 hours

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

Get in touch for your in-house training course

Inhouse Course*

Email*

First Name*

Last Name*

Company*

Country*

Your Notes*

Market of interest*

CosmeticsNutraceuticalsMedical DevicesPharmaceuticals

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.

In-house Training

Get in touch for your in-house training course

CosmeticsNutraceuticalsMedical DevicesPharmaceuticals

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.

Markets

Latest News

The Group

Company Information

Privacy settings

With the slider, you can enable or disable different types of cookies:

This website will

This website won't

This website will

This website won't

This website will

This website won't

This website will

This website won't

This website will

This website won't