MDR consulting, QMR, PRRC & QM systems

MDR consulting, QMR, PRRC & QM systems

Regulatory Affairs, Regulatory Certifications

Information

We support you as a regulatory partner in all challenges related to the MDR – individually, hands-on, and with responsibility. Our focus is on tailor-made solutions to ensure your regulatory compliance – from consulting to taking on defined roles. Our services include: Consulting on MDR, IVDR, ISO 13485, EUDAMED, and technical documentation Establishment and maintenance of quality management systems in accordance with ISO 13485 Assumption of the role of QMR (Quality Management Representative) Provision of a PRRC (Person Responsible for Regulatory Compliance) Audit preparation (internal, supplier, authority, notified body) Whether as short-term support or a long-term partner – we strengthen your processes, reduce risks, and ensure sustainable compliance.
Bytec Legal Manufacturer GmbHS9.C96BYTEC Legal Manufacturer GmbH is a young, dynamic company based in Germany with an international outlook. As a subsidiary of BYTEC Medizintechnik GmbH, our established parent company and ODM for medical devices with core competencies in production, SW & HW and system development, we combine long-standing industry experience with a forward-thinking, hands-on approach. BYTEC Legal Manufacturer GmbH specializes in development, regulatory affairs, and quality management consulting, including QMB and PRRC services, supporting sustainable market access, medical technology diversity, and better patient care. As your legal manufacturer, we take responsibility for regulatory approvals, market access, documentation, and quality management to ensure MDR compliance, so you can focus on your core business. Your brand remains fully yours, and we appear only in small print on the device label. As your EU representative, we support non-European manufacturers in placing products on the European market efficiently and in full regulatory compliance. Your added value: quality, reliability, and foresight.

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