Medical Device Regulatory Consultancy for UK, EU & FDA Compliance

Patient Guard specializes in medical device and IVD (In-Vitro Diagnostic) regulatory consultancy. We provide expert support for CE Marking, UKCA marking, ISO 13485 Quality Management Systems (QMS) implementation, and FDA submissions to ensure your medical products meet global safety and performance standards.

We guide manufacturers through the entire technical documentation process. This includes creating and updating Technical Files, conducting Clinical Evaluations, and ensuring compliance with the latest EU MDR (2017/745) and IVDR (2017/746) regulations, as well as the UK Medical Device Regulations.

Yes. For non-UK manufacturers looking to sell in the United Kingdom, Patient Guard provides a designated UK Responsible Person service. We manage your MHRA registrations, maintain technical documentation, and act as your official liaison with UK regulatory authorities.

Our consultants provide end-to-end support for ISO 13485 implementation. This includes performing a gap analysis of your current systems, developing compliant QMS documentation, conducting internal audits, and providing full support during your Stage 1 and Stage 2 certification audits.

Absolutely. We help manufacturers establish robust Post-Market Surveillance plans and Vigilance reporting systems. Our team ensures that any adverse events are reported correctly to the relevant authorities and that your device’s safety and performance are monitored continuously after market launch.

Yes. We provide comprehensive Risk Management services in accordance with ISO 14971, ensuring that all potential hazards are identified and mitigated throughout the device lifecycle. Additionally, we author and update Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) to demonstrate the ongoing safety and clinical benefit of your products.