Regulatory affairs
Ensuring quality and compliance
Do you need support in setting up a quality management system? Would you like to manufacture or market a medical device or in-vitro diagnostic product under your own name? You do not have the expertise to cover the position of QMB or PRRC in your company?
Are you tired of dealing with Europe’s complex and constantly evolving regulations?
We’re here to help! Whether you offer medical devices or in vitro diagnostic medical devices, our regulatory consulting and services help you get them to market, with confidence – and within the law.
Quality management (QM)
We offer our clients ongoing operative QM support and training to help their companies to achieve and sustain consistently high standards. Our goal is to ensure compliance with current regulatory requirements in Germany and Europe.
Expert guidance on MDR and IVDR compliance
Clients who have to deal with the EU Medical Devices Regulation (MDR) and/or In Vitro Diagnostic Regulation (IVDR) can rely on guidance from our experienced consultants.
We also offer support in reviewing and preparing technical documentation in accordance with MDR 745/2017 and IVDR 746/2017.
We support you in building a DIN EN ISO 13485-compliant Quality Management System by analyzing your current processes, identifying gaps, and designing a tailored implementation strategy. Our services include creating necessary documentation, such as the Quality Manual and procedures, and conducting employee training to ensure alignment with the standard. Finally, we assist with internal audits and prepare your organization for successful certification.
Our teams offer members general ISO 13485 consulting for improved quality – as well as carrying out internal audits within the framework of ISO 13485:2021.
We also provide our clients with an external QMO (Quality Management Officer) or Person Responsible for Regulatory Compliance (PRRC), if needed. If you are a non-EU medical device manufacturer, we can also provide a European Community Representative (EC-REP, EU-REP).
Beyond these specialized topics, our consulting team offers comprehensive support on a broad range of regulatory topics. This includes expertise in risk management, clinical evaluation, usability, software lifecycles and post-market surveillance, ensuring your company is fully equipped to meet all relevant regulatory challenges.
leap:up supports BellaSeno's international expansion, regulatory challenges, and strategic partnerships.
BellaSeno
Mohit Chhya, CEO
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