At be-on-quality, we specialise in regulatory compliance services that go beyond documentation. We actively support startups in all key regulatory affairs activities, from product classification, conformity assessment strategy, and regulatory pathway planning to compiling and maintaining technical documentation, clinical evaluation reports, and post-market surveillance systems. We liaise with Notified Bodies and Competent Authorities, manage submissions, and ensure the startups' product lifecycle remains compliant with MDR, IVDR, and international regulations. Our goal is to streamline the startup's market access and keep their innovations aligned with evolving legal requirements, so that they can focus on delivering safe, effective medical devices to patients worldwide. Outcomes can vary between prodict descriptions and classification, Regulatory Affairs Strategy documents to full technical files.
Depending on the specific case, we work in combination with the manufacturer. Hourly rate at €115.
Coaching & Mentoring
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Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project webiste.
Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.