Patient Guard

Professional UK Responsible Person (UKRP) services for non-UK medical device and IVD manufacturers, ensuring regulatory compliance and market readiness for the Great Britain market under UK MDR 2002.

Ensure your smooth entry into the UK cosmetics market with a UKRP you can trust. Includes PIF and CPSR Review, registration on SCPN database, and support with OPSS communications.

Person Responsible for Regulatory Compliance service ensuring medical device manufacturers meet regulatory obligations under EU MDR and IVDR effectively.

Outsourced Person Responsible for Regulatory Compliance (PRRC) support aligned with Article 15 of EU MDR and IVDR requirements.

Comprehensive support and guidance to help medical device manufacturers achieve FDA clearance efficiently, from determining substantial equivalence to preparing detailed documentation.

Expert guidance through the US 510(k) clearance process, supporting predicate device selection, evidence planning, and preparation of structured submissions.

Ensure medical device safety and regulatory compliance with expert ISO 14971 risk management support. Patient Guard develops compliant risk management plans, risk analyses, and risk management reports aligned with EU MDR, UKCA, and global regulatory expectations.

Learn the principles of medical device risk management in accordance with ISO 14971 and understand how to implement effective risk management processes throughout the product lifecycle.

Information security management system support for organisations implementing ISO 27001 and improving cyber security governance.

Quality management system implementation, improvement and audit support for medical device organisations.

An evaluation tool to determine compliance under Article 2(2) criteria of the EU IVDR 2017/746 for software pipelines, clinical assay inputs, or bioinformatics platforms.

An online regulatory tool designed to assess whether a product, apparatus, or soft-concept layout meets the statutory definitions of a medical device under EU MDR 2017/745 and MHRA rules.

Ensure ongoing compliance and certification readiness with expert ISO 27001 quality audits.

Expert-led internal auditing services to assess the effectiveness and compliance of medical device Quality Management Systems (QMS) against ISO 13485:2016 requirements.

Independent process audits to assess the effectiveness of your ISO 9001 QMS and prepare for external surveillance or recertification audits.

Ensure ongoing EU MDR compliance with expert Post-Market Clinical Follow-up (PMCF) support. Patient Guard develops PMCF plans, supports clinical data collection, and prepares PMCF Evaluation Reports to demonstrate continued safety, performance, and benefit-risk acceptability.

Ensure regulatory compliance and market readiness with expertly prepared PMS Plans, PMS Reports and PSURs.

Establish ongoing processes for monitoring IVD quality, safety and performance, including PMS Plans, PMS Reports, and Periodic Safety Update Reports.

Establish and maintain effective post-market systems for gathering, reviewing and acting on information about device quality, performance and safety.

Develop PMPF Plans and Evaluation Reports to proactively confirm continued IVD performance and identify emerging risks.

Comprehensive practical European In Vitro Diagnostic Regulation training covering regulatory compliance, classification, performance evaluation, technical documentation, and post-market surveillance.

Gain a practical understanding of the European Medical Device Regulation (EU MDR 2017/745) and its requirements for manufacturers, importers, distributors and authorised representatives.

A comprehensive full-day practical training workshop covering advanced ISO 14971 risk management methodologies and real-world examples.

Ensure quality compliance and certification readiness with expert ISO/IEC 27001 implementation support. Pricing starts from £6,750 for a basic implementation.

Implement a structured Information Security Management System to manage information security risks and safeguard sensitive data.

Independent auditing of your Information Security Management System to identify compliance gaps and support certification preparation.

Practical medical device quality management system training combining standard requirements with practical industry knowledge to support manufacturers, start-ups, and quality professionals.

An introductory half-day live online instructor-led training course on ISO 14971 risk management for medical devices.

Comprehensive layout configuration to construct high-grade manufacturing practices complying with FDA expectations.

System audits engineered to align your operational workflows with strict FDA Quality System Regulation criteria.

Expert regulatory affairs and quality assurance consultancy supporting medical device manufacturers through the entire device lifecycle, from classification and clinical evaluation to market access.

Preparation and review of technical files for CE marking, UKCA marking and regulatory submissions.

Specialized service for CE and UKCA medical device technical file creation and management, facilitating compliance with regulatory requirements.

Prepare Technical Documentation structured to support medical device market access in Great Britain against the UK Medical Devices Regulations 2002.

Expert compilation, review, and remediation of EU MDR 2017/745 Technical Documentation to ensure audit-ready dossiers for Notified Body submission.

Flexible monthly consultancy to help medical device, IVD, and digital health organisations maintain compliance, manage regulatory changes, support their Quality Management System, and meet post-market obligations.

Expert support and consulting for digital health technology to meet NHS clinical safety requirements, implementing Clinical Risk Management in accordance with DCB0129 and DCB0160.

Comprehensive regulatory, clinical safety, quality, and governance consultancy service designed to help digital health and medical device companies prepare for successful NHS procurement and market access.

Hands-on consultancy service to help organisations implement policies, documentation, and evidence needed to meet the NHS Digital Technology Assessment Criteria (DTAC) and prepare for NHS procurement.

Outsourced PRRC support for eligible manufacturers and Authorised Representatives under the EU MDR and IVDR.

An expert-led compliance assessment that identifies gaps, reviews existing evidence and provides a prioritised roadmap towards Digital Technology Assessment Criteria (DTAC) compliance for digital health technologies.

Professional EU Authorised Representative services tailored to medical device and IVD manufacturers, ensuring documentation, labelling, and regulatory obligations meet EU MDR requirements.

UKCA marking technical file preparation service for Class A in vitro diagnostic medical devices.

Expert regulatory support to prepare, review, remediate, and maintain IVDR-compliant technical documentation for In Vitro Diagnostics, supporting the transition from IVDD to IVDR (EU 2017/746).

Clinical evaluation services supporting medical device manufacturers in developing compliant Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in line with EU MDR requirements.

Ensure your smooth entry into the EU cosmetics market with an EURP you can trust. Includes PIF and CPSR review, registration on CPNP database, and support with EU authorities.

Expert consulting services for medical device manufacturers to prepare, review, and strengthen Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in compliance with ISO 10993 and global regulatory expectations.

End-to-end support to implement an ISO 13485 Quality Management System tailored to your organisation.

Expert support to navigate product qualification as a medical device, identify correct FDA classifications, and understand regulatory pathways.

Reduce uncertainty by seeking formal FDA feedback before completing product development or preparing a regulatory submission.

Designated Cosmetics Responsible Person service ensuring compliance with legal requirements of EU and UK cosmetic regulations.

Quality Management System implementation service tailored to help medical device manufacturers establish and maintain robust quality systems compliant with ISO 13485.

Professional UK Authorised Representative (UKAR) service for PPE manufacturers based outside Great Britain, ensuring compliance with UKCA requirements and the Personal Protective Equipment Regulations 2016.

Patient Guard maintains a BSI EN ISO 13485:2016 certified Quality Management System.

An interactive wizard engineered around MDCG 2019-11 and MDCG 2021-24 data-processing boundaries to validate digital health systems and AI engines.

Expert assistance to prepare for and navigate FDA pre-submission meetings to gain early feedback and clarify regulatory expectations.

Quality system implementation support for medical device manufacturers seeking to meet FDA requirements.

Tailored implementation services to help medical device manufacturers design and establish a quality management system complying with FDA 21 CFR Part 820 (QSR).

Customized private EU IVDR training blocks for operations seeking targeted regulatory integration and technical asset development support.

Develop a practical ISO 9001 Quality Management System designed around your organisation's processes, objectives and operational needs.

Comprehensive Post Market Surveillance (PMS) and Vigilance services ensuring timely detection and reporting of adverse events.

Post Market Clinical Follow-up (PMCF) services ensuring ongoing assessment of device safety post-market release.

Develop Performance Evaluation Plans and Reports integrating scientific validity, analytical performance and clinical performance evidence.

Expert internal audit services to assess quality management systems, identify gaps, and provide actionable recommendations aligned with FDA expectations.

Expert support and guidance to respond to and remediate FDA Form 483 or warning letters, including corrective action planning and root cause analysis.

A tool grounded in MDCG parameters and the Helsinki Procedure consensus to analyze products sitting between drug delivery systems, biocides, cosmetics, or lifestyle software.

Systematic scientific literature reviews demonstrating the association between an analyte or marker and the relevant clinical condition.

Internal Audit services tailored to medical device manufacturers, assisting in the assessment and improvement of quality management systems.

Specialized guidance for medical device manufacturers through the Investigational Device Exemption (IDE) submission process to facilitate clinical trials in the U.S.