Person Responsible for Regulatory Compliance (PRRC), Medical Devices.

You need a PRRC if you manufacture medical devices, or act as an EU authorised representative, under the Medical Device Regulation. Companies engage MEDCOR when they cannot meet the requirement in-house, when they need independent oversight, or when they need cover during an absence, a holiday or a transition.

• —Acting as your Person Responsible for Regulatory Compliance under MDR Article 15.
• —Backup PRRC cover during absence, holidays or a period of transition.
• —Review of technical documentation and device conformity before release.
• —Oversight of post-market surveillance and vigilance reporting.
• —Support for manufacturers and EU authorised representatives meeting their MDR obligations.

You get an experienced industrial pharmacist taking the PRRC role personally, with direct accountability for your device compliance. Whether you need the role held outright or covered as backup, you deal with the same person throughout.