Medical Device HQ
Medical Device HQ is a provider of specialized training courses, templates, articles, and resources for professionals in the medical device industry. They focus on regulatory compliance, risk management, design control, usability engineering, quality management systems, and safety standards such as IEC 60601, ISO 13485, and ISO 14971. Their mission is to support medical device companies and professionals in achieving regulatory compliance, developing safe and effective devices, and maintaining high-quality management systems.
Industries
Nr. of Employees
small (1-50)
Medical Device HQ
Lund, Skane Lan, Sweden, Europe
Products
Advanced Risk Management for Medical Devices — Online / Blended course
Intermediate–advanced training covering risk management system structure, analysis, control, traceability and common pitfalls; delivered via pre-recorded videos, quizzes and a final timed exam. Blended option includes classroom workshops and templates.
Introduction to Quality Management for Medical Devices — Online course and ebook
Foundational course and illustrated guide covering ISO 13485 requirements, QMS structure, documented procedures, supplier control, audits, process validation and practical implementation examples.
Introduction to Safety for Electrical Medical Devices and IEC 60601 — Online / Blended course
Course covering general safety and performance requirements for electrical medical devices, reasonably foreseeable misuse, single-fault conditions and power-supply considerations, and how to map requirements into risk and test plans.
Software for Medical Devices and IEC 62304 — Online / Blended course
Training on medical-device software lifecycle, management of third-party software components, documentation requirements, software risk assessment and maintenance practices aligned with IEC 62304 and regulatory guidance.
Advanced Risk Management for Medical Devices — Online / Blended course
Intermediate–advanced training covering risk management system structure, analysis, control, traceability and common pitfalls; delivered via pre-recorded videos, quizzes and a final timed exam. Blended option includes classroom workshops and templates.
Introduction to Quality Management for Medical Devices — Online course and ebook
Foundational course and illustrated guide covering ISO 13485 requirements, QMS structure, documented procedures, supplier control, audits, process validation and practical implementation examples.
Introduction to Safety for Electrical Medical Devices and IEC 60601 — Online / Blended course
Course covering general safety and performance requirements for electrical medical devices, reasonably foreseeable misuse, single-fault conditions and power-supply considerations, and how to map requirements into risk and test plans.
Software for Medical Devices and IEC 62304 — Online / Blended course
Training on medical-device software lifecycle, management of third-party software components, documentation requirements, software risk assessment and maintenance practices aligned with IEC 62304 and regulatory guidance.
Services
Self-paced online modules, blended formats with instructor-led sessions, and tailored in-house training covering risk management, quality management (ISO 13485), design control, usability engineering, internal auditing, IEC 60601 test planning and medical-device software lifecycle topics.
Customised proposals, group account setup for learner administration, tracking of participant progress and assessment results, and volume licensing arrangements for organisational training needs.
Distribution of practical templates (risk management plans, hazard traceability matrices, CAPA forms, complaint forms, DHR/DHF templates) to support QMS and risk-management processes.
Support for enrolment, payments, exam registration and certificate retrieval for course participants and purchasing administrators.
Self-paced online modules, blended formats with instructor-led sessions, and tailored in-house training covering risk management, quality management (ISO 13485), design control, usability engineering, internal auditing, IEC 60601 test planning and medical-device software lifecycle topics.
Customised proposals, group account setup for learner administration, tracking of participant progress and assessment results, and volume licensing arrangements for organisational training needs.
Distribution of practical templates (risk management plans, hazard traceability matrices, CAPA forms, complaint forms, DHR/DHF templates) to support QMS and risk-management processes.
Support for enrolment, payments, exam registration and certificate retrieval for course participants and purchasing administrators.
Expertise Areas
- Risk management for medical devices (ISO 14971)
- Quality management systems and ISO 13485 implementation
- Design control and design review processes (QSR / 21 CFR 820)
- Usability engineering and instructions-for-use integration (IEC 62366-1)
Key Technologies
- HTML5-based e-learning delivery and LMS features
- Electronic QMS and validation of software used in QMS
- IEC 60601 test protocols and type-testing methodology
- IEC 62304 software lifecycle processes
News & Updates
GCP is an international quality standard that governments can transpose into regulations that decide how clinical trials involving human subjects must be managed. Understanding the GCP principles allows for a successful setup and management of clinical studies and collecting data that can stand up to regulatory scrutiny.
The ISO 14155 standard has undergone some changes in its 2020 edition, mainly in order to ensure that the standard continues to keep its global acceptance by regulatory authorities. This article will present the main changes compared to the previous version of the standard.
Every stakeholder within the MDR has their own roles to fulfil, and in the medical device industry, it is of great importance to know exactly what those roles are, as is to know the difference between the stakeholders and economic operators.
This article provides a summary of the Unique Device Identifier (UDI) requirements. UDI will be applicable to all manufacturers of medical devices in the EU. Please note, the UDI requirements in the EU are not identical to the UDI requirements of other markets, like the US market.
Clinical research is necessary to develop new treatments for different diseases and conditions that occur in humans. To develop these new treatments, clinical trials have to be performed to get proof that the new treatment works and that it is safe.
This article focuses on the purpose and scope of essential SOPs (Standard operating procedures) and controlling documents in a QMS. It also covers how and why you should write a thought-through purpose for your SOP or controlling document and how this impacts efficiency.
GCP is an international quality standard that governments can transpose into regulations that decide how clinical trials involving human subjects must be managed. Understanding the GCP principles allows for a successful setup and management of clinical studies and collecting data that can stand up to regulatory scrutiny.
The ISO 14155 standard has undergone some changes in its 2020 edition, mainly in order to ensure that the standard continues to keep its global acceptance by regulatory authorities. This article will present the main changes compared to the previous version of the standard.
Every stakeholder within the MDR has their own roles to fulfil, and in the medical device industry, it is of great importance to know exactly what those roles are, as is to know the difference between the stakeholders and economic operators.
This article provides a summary of the Unique Device Identifier (UDI) requirements. UDI will be applicable to all manufacturers of medical devices in the EU. Please note, the UDI requirements in the EU are not identical to the UDI requirements of other markets, like the US market.
Clinical research is necessary to develop new treatments for different diseases and conditions that occur in humans. To develop these new treatments, clinical trials have to be performed to get proof that the new treatment works and that it is safe.
This article focuses on the purpose and scope of essential SOPs (Standard operating procedures) and controlling documents in a QMS. It also covers how and why you should write a thought-through purpose for your SOP or controlling document and how this impacts efficiency.