About us
In a nutshell
EUMEDIQ was founded in Frankfurt in May 2020, when MDR and IVDR in Europe required more organisational activities and also caused a degree of insecurity within the MedTech industry. Today, we help medical device manufacturers to bridge the gap between highly complex regulations in this industry and the simplest possible implementation in practice.
EUMEDIQ is a service provider for MedTech manufacturers consisting of a team of highly qualified experts with extensive knowledge in the medical device field. We support you in Authorised Representation (European Union, Switzerland and United Kingdom), consulting (especially management systems and regulatory affairs), auditing and interim management. Furthermore, we act as an importer for foreign medical device manufacturers in Switzerland. Our employees have extensive experience in the field of medical device regulations, management systems (ISO 13485, ISO 27001) incl. auditing, information security and data privacy topics. Therefore, we maintain our own management system according to ISO 13485:2016 and ISO 27001 because “we live up to our promise and do what we say”. These standards allow us to be an outstanding service provider for medical device manufacturers.
Our team
Each of our consultants brings more than 10 years of experience in the medical device, healthcare, and clinical environments, as well as regulatory and quality management. We specialise in tailoring processes to suit the specific needs of our clients. As experts in digitalisation and being digital natives, we have the knowledge and capability to establish digital processes and understand IT architectures – without requiring extensive explanations from your side. With ISO 13485, ISO 27001 and IPMA Project Management certifications, we are able to digitise your management system and implement your project.
Natalie Rosenbach
Managing Director EUMEDIQ GmbH
Experience
Managing Director of EUMEDIQ GmbH. +10 years of experience in health care environments and clinical research environments as a nurse, quality manager and clinical research associate. Natalie is responsible for our site in Frankfurt, Germany.
Lisa Kamber
Senior Consultant
Experience
Senior Consultant. +10 years of experience in medical device & clinical environments with solid expertise in the qualification & validation of the manufacturing processes of implants and consumables. She also has a profound understanding of clinical laboratory processes and extensive experience in Kanban methodology. Lisa acts as a TÜV Süd certified Safety Expert non-active medical devices and has a Master of Science in Biomedical Engineering from the Swiss Federal Institute of Technology, Zurich (ETH).
Mike Seidenberg
CEO & Founder
Experience
Senior Consultant, Founder and CEO at EUMEDIQ. +10 years of leadership experience in the quality management & regulatory affairs positions of globally known medical device companies. +10 years of experience as Person Responsible for Regulatory Compliance. Solid experience in dealing with critical regulatory situations concerning the Notified Bodies and National Competent Authorities. Mike is an IRCA certified Lead Auditor (BSI) for ISO 13485 and ISO 27001 & certified Manager of Regulatory Affairs Medical Device International (TÜV Süd). Also he is a certified Safety Expert for active medical devices (TÜV Süd).
Unja
Good Clinical Pawctices (GCP) Specialist
Experience
As a Good Clinical Pawctices (GCP) Specialist, Unja has taken it upon herself to uphold the highest standards of “Good Girl” conduct in the office. With an exceptional nose for compliance and a heart for belly rubs, she ensures that all office procedures meet the most rigorous sniff-standards. Unja’s daily GCP routine includes diligently checking treat distribution, enforcing cuddle breaks, and strictly overseeing all belly rub protocols. No document leaves her desk without a final paw approval–ensuring quality assurance at the very highest level.
Beatrice Kirchner
Senior Manager Marketing & Communication
Experience
Senior Manager Marketing & Communication at EUMEDIQ. 7+ years of experience in various aspects of marketing and sales operations, including communication, campaign management, project management, and sourcing. Background in service marketing, IT, and consulting within the life sciences sector. Specialist for public and media relations, brand management, marketing and market strategy with expertise in developing strategic marketing and communication plans for the medical device industry.
Anina Véliz-Velásquez
Accounting, Administration & Import
Experience
Anina assures that everything in the background is done in an accurate manner. This not only relates to payments, billing, VAT, expenses and controlling. She also takes care about all import transactions and customs control matters. Anina has worked several years as store manager for both, consumer retail and fast food restaurant where she gained her federal diploma of restaurant services. In addition, Anina has gained experience as an accountant in a trustee office.
Ramin Amiri
Regulatory Affairs Manager
Experience
Amina Sadikovic
Regulatory Affairs Manager
Experience
Amina has around five years of experience in Quality Management within the MedTech sector, with in-depth knowledge of regulatory requirements. Her primary roles have involved vigilance and complaints handling, as well as maintaining communication with regulatory bodies. Amina has also played a key part in the maintenance and optimisation of Quality Management Systems (QMS). Additionally, she has supported MDSAP audits and has been involved in inspections from authorities such as the FDA and Swissmedic.