Hannover-Braunschweig-Göttingen-Wolfsburg Region
With over 20 years of experience in global medical device regulatory affairs, I’ve spent my professional life immersed in the world of medical device regulations—helping companies bring their innovations safely and compliantly to global markets. My journey began at the Notified Body TÜV Rheinland in the United States, where I gained firsthand insight into the regulatory expectations from both sides of the Atlantic. That experience laid the foundation for what would become a lifelong passion: supporting manufacturers in navigating complex, ever-evolving compliance environments. I am the owner of MDSS GmbH and over the years, I’ve founded several organizations that reflect this mission, including MDSS Consulting GmbH, as well as international affiliates in the UK, Switzerland, USA, and Australia. These companies serve as strategic partners for medical device and IVD manufacturers worldwide—offering expertise on EU MDR and EU IVDR, and global regulatory pathways. Beyond my companies, I’ve had the privilege of contributing to the broader regulatory community: - Founding Member and Chair of the European Association of Authorized Representatives (EAAR) - Founding Member of the UK Responsible Person Association (UKRPA) - Member of the Ethics Committee of the Medical Council for Lower Saxony - Founding Member of the RAPS Germany Chapter and long-standing RAPS USA member - EAAR representative on the EU’s Medical Device Coordination Group (MDCG and MDCG-PMSV) My work is driven by the belief that compliance and innovation should go hand in hand—and that strong regulatory guidance can help great products reach patients who need them most. I’m always open to connecting with peers and partners who share that same vision.
MDSS NZ Ltd specializes in the Sponsor service and provides regulatory and strategic advice for MD / IVD manufacturers located outside New Zealand.
MDSS AU Pty Ltd specializes in the Sponsor service and provides regulatory and strategic advice for MD / IVD manufacturers located outside Australia.
The European Association of Authorised Representatives (EAAR) is the European association representing organisations that provide Authorised Representative services to non-European manufacturers of medical devices and in vitro diagnostic medical devices. Established to promote professionalism, competence, and high standards in European Authorised Representation, EAAR serves as a unified voice for the sector and advocates for quality, compliance, and regulatory excellence. Officially recognised by the European Commission, EAAR actively engages with regulators, Competent Authorities, Notified Bodies, and industry stakeholders, contributing to discussions on European medical device legislation and market access requirements. The association also works to strengthen understanding of the critical role and responsibilities of Authorised Representatives in supporting manufacturers' compliance with European regulatory frameworks.
MDSS CH GmbH specializes in the Swiss Authorised Representative service and provides regulatory and strategic advice for MD / IVD manufacturers located outside Switzerland.
The UK Responsible Person Association (UKRPA) is the professional association representing companies and individuals performing the role of UK Responsible Person (UKRP) for medical device manufacturers placing products on the Great Britain market. Established in 2020, the association promotes professionalism, competence, and high standards in the delivery of UK Responsible Person services, helping to ensure effective compliance with UK medical device regulatory requirements. Founded by experienced regulatory service providers with extensive expertise in authorised representation and medical device compliance, UKRPA serves as a collaborative forum for organisations and professionals acting as UKRPs. The association works to advance best practices, support professional development, and foster excellence across the sector. UKRPA engages closely with the Medicines and Healthcare products Regulatory Agency (MHRA) and other stakeholders to enhance transparency, encourage regulatory understanding, and contribute to discussions affecting the medical devices industry. Through advocacy, education, and stakeholder engagement, the association supports a consistent and effective approach to fulfilling the responsibilities of the UK Responsible Person under UK medical device legislation.