Medical device hq instructors
At MDHQ, we are on a mission to streamline the path to bringing medical devices to market efficiently. Our courses are meticulously designed to empower professionals from small and medium-sized medical device companies.
What sets our training apart is the expertise of our instructors. These are not just educators; they are industry leaders with extensive practical experience and a deep understanding of the nuances of medical device development. Many of Medical Device HQ instructors have successful business careers, and a majority of them actively contribute to industry standards as members of standardization committees.
Meet Medical Device HQ instructors and course creators
Christian Kaestner
Medical device software expert at Medical Device HQStandardization committee member
SME for online courses, instructor for classroom sessions of public and in-house courses:
• SAMD, IEC 62304 and IEC 82304-1
• Software for Medical Devices and IEC 62304
• Agile Medical Device Software Development
Christian Kaestner is a consultant and trainer with a wealth of knowledge about the medical device industry. He is an expert member of the project team authoring IEC 62304 and also actively participated in the creation of IEC 82304-1.
He has extensive experience of medical device development and, as a software developer, a strong dedication to software development. In the software domain he has worked in many roles such as software developer, project manager, auditing and quality management.
Claus Rømer Andersen
CEO, Owner, Technical Advisor at Rømer Consulting ApS
Standardization committee member
SME for online courses, instructor for classroom sessions of public and in-house courses:
• Safety for Electrical Medical Devices and IEC 60601
• Design Control for Medical Devices – Practitioner Training
• Risk Management for Medical Devices and ISO 14971:2019 – Practitioner Training
Claus Rømer Andersen is an accomplished trainer, consultant and facilitator in the medical device industry. With a background in electrical engineering, he has worked with regulatory navigation, approval management, device testing throughout his whole career.
He is recognized as having a pragmatic and solution oriented approach to helping development teams focus on relevant issues throughout the entire product life-cycle.
Helena Hjälmefjord
Project Leader – Regulatory compliance at Fjord Consulting AB
SME for online courses, instructor for classroom sessions of public and in-house courses:
• Process Validation for Medical Devices
• Medical Devices Requirements Engineering – Practitioner Training
• Design Control for Medical Devices – Practitioner Training
Helena Hjälmefjord has extensive experience within the medical device industry, Class I to Class III devicesand In-Vitro diagnostics;as well as with allografts (human tissue). Amongst others she has worked as project leader, quality manager as well as design control and regulatory assurance lead. Helena has worked in both small companies as well as large international companies. Since 2014 she works through her own consultant company, Fjord Consulting.
Helena’s motivation is getting customers to understand the importance and benefits of the regulations that are placed on their medical device products and related processes.
Jonas Walter
Head of Operations, Senior Consultant and Lead Trainer at Custom Medical
Medical Device HQ instructor for classroom sessions of public and in-house courses
• Usability Engineering and IEC 62366-1 – Practitioner Training
Dr. Jonas Walter is Head of Operations, Senior Consultant and Lead Trainer at Custom Medical. With a background in psychology and neuroscience, he is the company’s lead expert for regulatory usability engineering worldwide, helping medical device and IVD manufacturers translate complex international requirements into efficient, compliant usability strategies.
He advises global manufacturers across all device classes on regulatory strategy, usability engineering, validation planning and lean documentation under MDR/IVD-R, FDA, IEC 62366-1 and NMPA requirements. His experience spans from low to high risk profile devices, including cardiac implants, neuroendoscopic class III devices, diabetes care, dental products, AI-enabled diagnostics and IVD applications. As a trainer, he has enabled more than 100 international professionals in regulatory usability engineering and human factors.
Maria Nyåkern
Founder and Owner at Nyakern Nexus
Standardization committee member
SME for online courses:
• Clinical Investigation for Medical Devices and ISO 14155
Maria Nyåkern, Ph.D., is an inspiring teacher and consultant with a long experience in the medical device industry as a clinical research scientist and entrepreneur across the spectrum of early-stage start-ups to large multi-national organizations. She has vast ‘hands-on’ experience, having set up and managed dozens of clinical investigations, with tens of thousands of patients, for different medical devices and many of the industry’s top ten medical device manufacturers.
Maria Nyåkern is part of the ISO committee, SIS/TK 340 and ISO/TC 194 Biological and clinical evaluation of medical devices, responsible for developing the ISO 14155 standard. She is an experienced consultant in clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard.
Dr. Nyåkern is a Doctor of Cell Biology at Stockholm University, Sweden (2003) and a Postdoctoral Fellow at the University of Bologna, Italy (2006).
Dr. Michaela Kauer-Franz
CEO at Custom Medical
Standardization committee member
SME for online courses, instructor for classroom sessions of public and in-house courses:
• Usability Engineering and IEC 62366-1
• Usability Engineering and IEC 62366-1 – Practitioner Training
Dr. Michaela Kauer-Franz is the CEO of Custom Medical, an award-winning company that designs user interfaces for medical devices and conducts formative and summative usability studies for all classes of medical devices. She holds lectures on the design of medical and critical user interfaces at the Technische Universität Darmstadt and is part of the national standardization committees in Germany for Usability and User Experience.
Dr. Michaela Kauer-Franz is a highly regarded trainer, consultant, and entrepreneur in the medical device industry. She has extensive hands-on experience, having developed, amongst other things, monitoring devices for ICU and NICUs, diabetes care products, and women’s health products. She has also received numerous awards including the Red Dot Winner Interface Design Award and being nominated for the UX Design Award.
Peter Sebelius
CEO and Founder at MDHQ
Standardization committee member
SME for online courses, instructor for classroom sessions of public and in-house courses:
• Design Control for Medical Devices
• ISO 13485 Internal Auditor Training
• Project Management for Product Development of Medical Devices
• Medical Device Requirements Engineering
• Risk Management for Medical Devices and ISO 14971:2019
• Introduction to Working in the Medical Device Industry
• Quality Management for Medical Devices and ISO 13485
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
Pontus Gedda
Founder and consultant at MD3 Sweden AB
SME for online courses, instructor for classroom sessions of public and in-house courses:
• The Medical Device Regulation (EU) 2017/745
• PRRC – Person Responsible for Regulatory Compliance
• Quality Management for Medical Devices and ISO 13485 – Practitioner Training
• Risk Management for Medical Devices and ISO 14971:2019 – Practitioner Training
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.
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