5AI Consulting Ltd

5AI delivers transformative solutions. We provide consultancy services, PRRC, and Authorised Representative within the UK and Europe. Our highly collaborative process starts with understanding the business requirement of the client and work together with the client to provide a tailored solution for the business to succeed. We create innovative solutions to the Medical device industry. We also provide regulatory and quality services to different sectors such as Robotics in Challenging environment, Medical Device Regulations and Invitro Diagnostics Regulations. Services we provide: - Gap assessment from MDD to MDR, IVDD to IVDR - PRRC, and UK Authorised Representative. - Writing, updating and reviewing technical files. - Providing remediation reviews from Notified Bodies. - MHRA Market Access Product Registration. - Regulatory Training services. - UKCA and CE Marking. - ISO13485 / ISO9001. - Training clients and consultants on different Standards and their applicability.

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