One of the requirements under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is that manufacturers must have a Person Responsible for Regulatory Compliance (PRRC) who possesses specific responsibilities and competency requirements.
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In smaller organisations, this individual can be external to the company, and in such cases, ReguLogix Consulting offer services to fulfil this role*. 
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For larger organisations, ReguLogix Consulting can provide standby support to the in-house PRRC for advice or a second opinion on issues, which also helps demonstrate the required competence of the PRRC. This arrangement ensures compliance with regulatory standards and enhances the effectiveness of the PRRC's role within your organisation.