Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs – Course
Learn about the IVDR and CE-marking of IVD medical devices. Understand the regulatory requirements for IVD medical devices. Understand the obligations under IVDR
GMP for
An online training course covering GMP requirements currently applicable to the manufacturing of material for clinical trials, phase variations, and upcoming regulatory changes.
GMP for QC technicians
A course that reviews new GMP trends and guidelines in quality control, focusing on requirements for chemical and microbiological quality control during drug manufacturing.
GMP for Quality Control for Pharmaceuticals
This course provides a basic understanding of Good Manufacturing Practice for Quality Control Laboratories in the pharmaceutical industry.
Clinical Development
Comprehensive clinical development services supporting medical device and IVD companies through every stage of clinical and regulatory evidence generation under MDR, IVDR, ISO 14155, and ISO 20916.
Clinical Development Training
Tailored courses and open trainings on ISO 14155 and ISO 20916 for medical devices and IVDs.
Auditor / Lead Auditor Course – Pharmaceuticals and Medical Devices
This tailor made training gives you the tools and skills required as Auditor or Lead Auditor in the Pharmaceutical and Medical Device industry.
Auditor/Lead Auditor – Läkemedel och medicinteknik
Denna specialanpassade utbildning ger dig de verktyg och färdigheter som krävs som Auditor eller Lead auditor inom läkemedels- och medicinteknisk industri.
Roadmap to Market
Training course focusing on Software as a Medical Device (SaMD) regulatory roadmap steps.
Roadmap to Market Step 1 – the EU
Training course focusing on the roadmap to market for the European Union.
Roadmap to Market Step 2 – US and the FDA
Training course focusing on the roadmap to market for the United States and the FDA.
Valid Statistical Techniques Made Easy Part 2
This training covers the application of valid statistical methods and tools to satisfy the requirements of the FDA's QSR and ISO 13485:2016.
Valid Statistical Techniques Made Easy Part 1
This training covers the application of valid statistical methods and tools to satisfy the requirements of the FDA's QSR and ISO 13485:2016.
Design, Development
A comprehensive two-day training course offering an overview of design, development, and regulatory requirements for traditional medical devices and modern digital health technologies, including EU MDR, IVDR, and FDA regulations.
CE-marking
Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation
CE Marking for Medical Devices and IVDs
Consulting and support services to guide medical device and IVD manufacturers through the CE marking process, compliance with EU MDR and IVDR regulations, QMS implementation, and technical documentation preparation.
Acceptance Sampling Plans: Inspection by
Training course on acceptance sampling plans using inspection by attributes for medical devices.
Acceptance Sampling Plans: Inspection by Variables
Training course on acceptance sampling plans using inspection by variables for medical devices.
Risk Management
An introduction package designed to facilitate compliance with EU regulations and enhance patient safety for medical devices and IVDs under ISO 14971:2019/A11:2021.
Risk Management for Medical Devices – ISO 14971 – Course
Get a good insight and understanding of the key requirements for a risk management system in compliance with EU regulations.
Internal Audit - Standard
2-day internal audit tailored for small to mid-sized organizations, addressing 2-3 criteria like ISO 13485, IVDR, and QSR.
Internal Audit - Extended
3-day internal audit suitable for mid-sized to large organizations with high-risk class products, covering 2-3 criteria.
Internal Audit - Light
1-day internal audit ideal for startups in early sales stages, focusing on 1-2 audit criteria such as ISO 13485 and MDR.
Test Method Validation (TMV) Made Easy – Part 1 Variable Measurements
Webinar to help evaluate measurement systems, diagnose problems, and fix them for variable measurements.
Test Method Validation (TMV) Made Easy – Part 2 Attribute Measurements
Webinar focusing on Attribute Measurement Systems – subjective inspection of items to see if they satisfy requirements.
Avatar-Based Compliance Training
Customized digital training programs built on regulatory expertise for Pharma and MedTech organisations, featuring scalable distribution, tests, certificates, and LMS integration.
eTMF
A user-friendly, cloud-based electronic Trial Master File (eTMF) system powered by Focalcube that simplifies clinical study documentation by providing a fully compliant solution for efficient document management, secure collaboration, and unlimited study flexibility.
GxP Compliance Training Programs
Tailored in-house, on-demand, and public training courses covering various aspects of GxP including GMP, GDP, GLP, GCP, and GVP.
GMP Basics 2.0 EN – Good Manufacturing Practice
Convenient, flexible and verifiable online training course in Quality Systems for the Life Science industry based on regulations and guidelines for Pharmaceuticals and Medical Devices.
Dataintegritet
Training course focused on data integrity principles and compliance requirements in life sciences.
Grundkurs i GMP och kvalitetssystem
Introduktion till de regelverk och riktlinjer som gäller vid tillverkning av läkemedel och medicintekniska produkter, dvs GMP och QSReg.
Clinical Investigations and Performance Studies
Comprehensive consulting and advisory services covering all phases of clinical studies for medical devices and in vitro diagnostics (IVDs) in alignment with ISO 14155 and ISO 20916.
Course in Quality Risk Management and Root Cause Investigations
An overview of QRM and RCI and the respective regulatory expectations. Common tools and methods for the Pharma and Medical Device industry.
GxP Comprehensive Consulting Services
Comprehensive services including Gap Analysis, Compliance Assessment, and strategic guidance on implementing necessary changes to meet GxP requirements.
Clinical Data Management Services
Full Clinical Data Management (CDM) services tailored for medical device and IVD studies, supporting everything from study setup to Post-Market Clinical Follow-up data outputs.
GMP Up-dates
A 3 hour on-line training course designed to meet GMP requirements for continuous staff training, covering updates and changes in EU and US GMP rules, PIC/S news, ICH news, and regulatory observations.
Corrective Action Planning
Training course focusing on corrective action planning.
GMP MasterClass course
Get a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements in pharmaceutical production.
Validation of software for QMS process
A training course on software assurance and validation for QMS processes covering ISO 13485, MDR, and QSReg requirements, risk assessment, and IQ, OQ, and PQ applications.
GMP-krav på datoriserade system – Kurs
Utbildning om de FDA och EU-regler och tolkningar som berör datoriserade och automatiserade system vid läkemedelstillverkning: 21 CFR 11 och EU GMP Annex 11
CAPA and root cause analysis, tools for an effective CAPA process – Course
Training course covering CAPA and root cause analysis tools for establishing an effective CAPA process.
EU GMP Annex 1 - Highlight of the new industry requirements
A professional webinar and course highlighting the major revisions and new industry requirements in the updated EU GMP Annex 1 guideline for the manufacture of sterile medicinal products.
MDR package deal for MDSW manufacturers
A tailor-made package deal designed to help Medical Device Software manufacturers achieve and maintain MDR compliance, including training, GAP analysis, and tailored workshops.
Quality Management System Integration
Services aiding in the development and optimization of a robust Quality Management System (QMS) tailored to align with GxP requirements.
Medical Device Software Development Process - Course
An in-depth training course in IEC 62304 providing software developers in the Medical Device and IVD industry with a clear understanding of software lifecycle requirements, safety classification, AI/ML considerations, and integration with risk management standard ISO 14971.
Effective root cause investigation for the Life Sciences
Training course addressing effective root cause investigation for the Life Sciences sector.
ISO 14155:2020 – Good Clinical Practice for Medical Devices (GCP)
Comprehensive hands-on training for planning, conducting, and documenting clinical investigations in compliance with MDR based on ISO 14155.
Qualification and Validation for Pharma and Medical Devices
The key principles and practices involved in qualification and validation. Learn about equipment qualification, process validation, and US and EU compliance.
QA Support
Hands-on quality support providing assistance with QMS updates, audits, risk management, and overall QA/RA activities.
GCP Audit Services for Medical Devices and IVDs
GCP audit services to help medical device and IVD manufacturers demonstrate control, compliance, and data integrity across clinical functions and studies.
ISO13485:2016 – from an auditing perspective
A one day online-course providing a full understanding of the requirements ISO13485:2016 place on a Quality Management System, including solutions from the 13485 Handbook and tools to perform efficient audits.
Safety Management for Medical Device and IVD studies
End-to-end Safety Management services for clinical investigations and performance studies covering medical devices and IVDs, aligned with ISO 14155, ISO 20916, and MDCG guidance.
IVDR in a nutshell – Technical Documentation course
A half-day training course designed to help build and structure the Technical Documentation (Technical File) for In-Vitro Diagnostic Devices to achieve CE-certificates under IVDR.
Cleaning validation of pharmaceutical process equipment – Course
Learn details for all part of the global cleaning validation strategy in pharmaceutical activities. CGMP expectations, technical and regulatory updates.
Medical Device Quality Management Systems Training
A comprehensive two-day on-site and half-day online course providing clarity and tools to implement and maintain a robust Quality Management System (QMS) aligned with EU and US regulatory expectations.
QA/RA Leader Medical Devices
Leadership training course for Quality Assurance and Regulatory Affairs professionals in the medical device field.
IVDR and requirements on the Quality Management System
A 1-day training course guiding participants through key IVDR requirements on the Quality Management System, gap analysis, updating quality management systems, ISO 13485:2016 relationship, and the role of the PRRC.
Pharma Quality Management System (QMS)
A structured framework of policies, processes, and procedures for medical device and IVD organizations to ensure products consistently meet customer requirements and regulatory standards throughout the entire product life cycle.
Starting materials – the GMP essentials
An informative webinar providing an overview of GMP requirements for starting materials, covering both EU GMP and US FDA requirements for APIs and excipients.
Quality Manager
Experienced support providing leadership, guidance, and PRRC responsibility to maintain QMS and regulatory requirements.
IVDR Compliance Consultation and Support Services
Comprehensive consulting and advisory services for In Vitro Diagnostic (IVD) manufacturers to achieve and maintain EU IVDR compliance, including gap analysis, technical documentation preparation, and QMS support.
Sampling – Medical Devices
How Much Is Enough for Process Validation? This training will cover the details of application without the burden of statistical complexity.
Clinical Affairs for Medical Devices and IVDs
Functional insourcing service for clinical development tailored to medical device and IVD companies, covering clinical strategy, documentation, project planning, regulatory interaction, and evidence generation.
Notified Body Review Support and Rescue Missions
Comprehensive consulting services supporting companies throughout the full regulatory process for medical devices and IVDs, including end-to-end support, gap analysis, and fast remediation for Notified Body reviews.
MDR Audit Readiness
An online training course that provides a full understanding of MDR specific requirements on your Quality Management System, including an exhaustive review of differences and similarities between ISO13485:2016 and MDR QMS requirements.
MDSAP – a global audit approach – Course
Learn how to plan perform and report internal MDSAP audits as well as best practice and tools how to be prepared to undergo or perform MDSAP audits.
QMSR - The FDA rev. of 21 CFR 820 in relation to ISO 13485:2016
A webinar course that covers the FDA Quality Management System Regulation (QMSR) Final Rule amending 21 CFR Part 820 and its relation to ISO 13485:2016.
Medical Device Supplier Control and Outsourcing – Course
Get tools and examples of best practice and learn how use the Plan – Do – Check - Act approach to control and verify the performance of your suppliers.
GMP requirements for Computer Systems and Data Integrity
Training course focusing on GMP requirements for computer systems and data integrity.
Becoming a Regulatory Affairs Manager for Medical Devices – Course
Get the knowledge and skills needed to lead the RA function at a medical device organization. Interpret and apply MDR, IVDR, and ISO 13485 effectively.
GMP Master Class (Svensk version)
Lär dig att förstå, navigera, tolka och tillämpa GMP enligt krav i både EU och USA, samt ICHs guidelines för kvalitetssystem och kvalitetsriskhantering.
Audit Service Agreement
Subscription-based comprehensive audit solution delivering ongoing regulatory excellence, audit program management, yearly internal audits, and vendor evaluations for a fixed monthly fee.
Are Your Data Normal or Not?
Training course focusing on data normality analysis for medical device compliance and statistics.
GIVIMP and GCCP for scientists – Course
Training course covering Good In Vitro Method Practices (GIVIMP) and Good Cell Culture Practice (GCCP) for scientists.
Deviation investigation and CAPA in the pharmaceutical industry – Course
This course focuses on root cause analysis and how to execute a successful CAPA management process from initial reporting to root cause analysis for the Pharmaceutical industry.
Medical Device Postmarket Surveillance – PMS
Training course on medical device postmarket surveillance (PMS) requirements and implementation.
Literature Search & Review for MDR Compliance – Practical Training
Learn how to effectively plan, perform, and document literature searches to meet MDR requirements, ensuring robust compliance and risk management.
Basic course in GLP – Good Laboratory Practice
Get the basic knowledge and understanding needed for working in a GLP environment. Learn to find your way in the OECD GLP and other relevant guidances.
IVDR Performance Evaluation, Risk Management, PMS and PMPF
Part 3 of the IVDR training series focusing on performance evaluation, risk management, PMS, and PMPF.
Medical Device Regulatory Consulting
Regulatory consulting services for manufacturers of aesthetic, beauty, and wellness products transitioning to or complying with EU MDR Annex XVI.
Change Management for Medical Devices – Course
How to apply a risk-based approach when managing changes to your medical device to ensure compliance, maintain quality, and ultimately protect patient safety.
Sterilization of Medical Devices Course
In-depth training on assessing suitability, adequacy and effectiveness of medical device sterilization methods.
Process validation – Medical Devices – Course
Gain increased knowledge about both the preparations required and the main parts that are included in process validation for medical devices.
GBA Key2Compliance PRRC Service
External PRRC (Person Responsible for Regulatory Compliance) service designed for organizations with fewer than 50 employees, ensuring full compliance with Article 15 of MDR 2017/745 and IVDR 2017/746.
Advanced Training in Biological Evaluation of Medical Devices
Learn how and when a biological evaluation, according to ISO 10993-1, should be performed. Understand the evaluation requirements and avoid common pitfalls!
Grundläggande statistik – Självstudiekurs
Self-study course in basic statistics for life sciences and medical device professionals.
Responsibilities of the PRRC – and methods to manage them
Get understanding of the responsibilities of the PRRC and how this can be defined within the organisation. Important also for CEO and top management.
Strategic communication course
Get tools for clear communication about e.g. requirements and expectations in different situations. Be seen as a positive leader that inspires quality work.
Roadmap to Market Step 3 – Medical Device QMS Introduction
Introduction course to medical device quality management systems (QMS) as part of the roadmap to market.
Basic Training in Biological evaluation of Medical Devices
Get fundamental knowledge to understand how and when a biological evaluation, according to ISO 10993-1, should be performed and avoid the most common pitfalls.
Technical Documentation for Medical Devices and IVDs
Consulting and support services for medical device and IVD manufacturers regarding technical documentation, risk management, evidence substantiation, and global regulatory compliance.
Validering och kvalificering
Få fördjupade kunskaper om de regulatoriska kraven kring validering och kvalificering vid läkemedelstillverkning och hur de appliceras.
Clinical Evaluation for Medical Devices
Comprehensive clinical evaluation support services for medical device manufacturers to build compliant clinical documentation under the EU MDR, including Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs).
Focalcube
An easy to use and competent cloud solution for quality management provided by Medos made available through GBA Key2Compliance.
Cybersecurity in Medical Device Lifecycle – Course
How to have your Medical Devices compliant with the cybersecurity requirements: risk management, design, development, maintenance, and post-market surveillance.
Validation of Analytical Procedures Made Easy – Course
What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality?
Usability for Medical Devices – Course
How do you know if the users think your device is “Easy to use”? Learn how to establish, implement and monitor a usability process.
Strategisk kommunikation – Utveckla din roll som QA
Vi går igenom verktyg för att på ett tydligt sätt kunna kommunicera ut till exempel krav och förväntningar i olika situationer. Dessa verktyg hjälper QA-personal att ses som positiva ledare som inspirerar i kvalitetsarbete.