Our Services
Medical Device, IVD, Cosmetic, PPE regulatory and quality Services from Patient Guard are industry leading.
Patient Guard has developed into one of the leading regulatory consultancies, trading since 2017.
Our experts have over 20 years experience in medical device, IVD, Cosmetic and PPE regulation and Quality Assurance. We work with all sizes of organisations from start-ups to large corporations. Being an established regulatory and quality assurance consultancy we have developed expertise in all areas of regulation and quality assurance, allowing you to choose just one consultancy that covers all your compliance requirements
Our medical device, IVD, Cosmetic, PPE regulatory and quality services are tailored to suit your needs, our aim is to ensure that you meet all of your regulatory and quality obligations, providing clear advice, mapping our your regulatory framework and strategy and holding your hand through out the process, giving you peace of mind that your projects are in safe hands. Please reach out to use and arrange a call with us to see how we can help you become and remain compliant.
Medical Device Consultancy
Patient Guard offers expert medical device regulatory and quality services, specializing in guiding medical device and IVD organizations through the complexity of the medical device regulations.
With a team of seasoned professionals, Patient Guard provides comprehensive assistance in regulatory compliance, product development, quality management, and risk assessment.
Our tailored approach ensures clients navigate complex regulatory frameworks efficiently, optimizing product performance and patient safety.
From concept to market, Patient Guard is dedicated to empowering clients to deliver innovative and compliant medical solutions that enhance patient care.
PRRC Services
Patient Guard’s PRRC (Person Responsible for Regulatory Compliance) service ensures medical device manufacturers meet regulatory obligations effectively.
With a keen understanding of European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements, Patient Guard can serve as a clients PRRC, establishing robust regulatory compliance processes.
By partnering with Patient Guard, manufacturers can confidently navigate the complexities of medical device compliance, safeguarding product integrity and ensuring continued regulatory adherence.
ISO 13485 QMS Implementation
Patient Guard’s Quality Management System (QMS) implementation service is tailored to help medical device manufacturers establish and maintain robust quality systems.
Using our extensive industry expertise and regulatory knowledge, Patient Guard guides clients through the process of developing QMS frameworks compliant with relevant standards such as ISO 13485.
From documentation and training to process validation and audits, our comprehensive approach ensures seamless QMS integration, fostering product quality, regulatory compliance, and ultimately, patient safety. Trust Patient Guard for expert assistance in optimizing your QMS.
Medical Device UK Responsible Person
Patient Guard’s UK Responsible Person service provides essential support for medical device manufacturers seeking compliance with UK regulations post-Brexit.
As a designated Responsible Person, Patient Guard assists clients in fulfilling their legal obligations, including registration with the UK Medicines and Healthcare products Regulatory Agency (MHRA), maintaining technical documentation, and ensuring ongoing compliance with UK legislation.
With Patient Guard as your trusted partner, navigate the complexities of UK market access seamlessly while upholding product safety and regulatory standards.
Medical Device EU Authorised Representative
Patient Guard offers a comprehensive EU Authorized Representative service, facilitating seamless access to the European market for medical device manufacturers worldwide. Acting as the designated representative, Patient Guard assists clients in fulfilling regulatory requirements outlined in the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
From regulatory submissions to post-market surveillance, Patient Guard ensures compliance every step of the way, enabling manufacturers to navigate the European market confidently and efficiently. Trust Patient Guard for expert EU representation and market access solutions. Patient Guard is well placed to support you in registering your Medical Devices on the EU market.
Biological Evaluation
Patient Guard delivers expert Biological Evaluation services to ensure the safety and efficacy of medical devices.
Compliant with ISO 10993 and other relevant standards, their comprehensive approach includes risk assessment, biocompatibility testing advice, and toxicological evaluations.
With a focus on patient safety and regulatory compliance, Patient Guard guides clients through each stage of the biological evaluation process, from initial assessment to final documentation.
Trust Patient Guard for meticulous evaluation of your medical devices, ensuring they meet stringent biocompatibility requirements.
ISO 13485 Internal Auditing Service
Patient Guard offers Internal Audit services tailored to medical device manufacturers, assisting in the assessment and improvement of quality management systems.
Our expert auditors conduct thorough audits to ensure compliance with quality standards including ISO 13485. Through meticulous review and analysis, our auditors will identify areas for enhancement, streamlining processes, and mitigating risks.
By partnering with Patient Guard for Internal Audits, manufacturers can strengthen their quality systems, achieve regulatory compliance, and enhance overall operational efficiency. Trust Patient Guard for comprehensive and effective internal audit solutions.
Medical Device CE Marking Technical Files (EU MDR)
Patient Guard specializes in CE medical device technical file creation and management, facilitating compliance with regulatory requirements for medical device manufacturers.
Our extensive expertise and knowledge of European regulations, ensure that technical files meet compliance requirements. From initial creation to ongoing management.
Patient Guard provides comprehensive support, enabling clients to navigate the complex regulatory landscape seamlessly while upholding product quality and safety standards.
Trust Patient Guard for expert guidance in technical file creation and management.
Clinical Evaluation
Patient Guard offers comprehensive Clinical Evaluation and management services tailored to medical device manufacturers. With a focus on regulatory compliance and patient safety, our experienced team conducts rigorous assessments to gather and analyse clinical data.
Patient Guard guides clients through each step of the evaluation process. By partnering with Patient Guard, manufacturers can ensure their medical devices undergo thorough clinical scrutiny, facilitating market approval and enhancing overall product effectiveness.
Trust Patient Guard for expert Clinical Evaluation and management solutions.
PMCF
Patient Guard provides expert Post Market Clinical Follow-up (PMCF) services to medical device manufacturers, ensuring ongoing assessment of device safety post-market release.
With a focus on compliance with regulatory requirements, our team designs and implements PMCF plans, gathers relevant data, and evaluates the effectiveness of devices in real-world settings.
By partnering with Patient Guard for PMCF, manufacturers can demonstrate continued product safety and efficacy, meet regulatory obligations, and enhance overall patient care. Trust Patient Guard for comprehensive PMCF solutions.
Post Market Surveillance (PMS) for Medical Device Manufacturers (EU MDR)
Patient Guard delivers comprehensive Post Market Surveillance (PMS) and Vigilance services to medical device manufacturers, ensuring timely detection and reporting of adverse events. With a proactive approach, our expert team monitors device performance.
Patient Guard assists in establishing robust vigilance systems, streamlining reporting processes, and maintaining compliance with regulatory requirements.
By partnering with Patient Guard, manufacturers can enhance patient safety, regulatory compliance, and overall product quality.
UK Cosmetics Responsible Person
As a designated Cosmetics UK Responsible Person, Patient Guard ensures compliance with the legal requirements of the UK cosmetic regulations, ensuring product safety.
Manufacturers who do not have a registered business in the UK are legally required to have a Cosmetics UK Responsible Person to register their products on the UK SCPN database.
EU Cosmetics Responsible Person
As a designated Cosmetics EU Responsible Person, Patient Guard ensures compliance with the legal requirements of the EU cosmetic regulations, ensuring product safety.
Manufacturers who do not have a registered business in the EU are legally required to have a Cosmetics EU Responsible Person to register their products on the EU CPNP database.
Cosmetics Product Information Files (PIF)
Patient Guard provides comprehensive Product Information File (PIF) services to ensure your cosmetic products meet the requirements of both the EU Cosmetics Regulation (EC) No. 1223/2009 and the UK Cosmetics Regulation, supporting full regulatory compliance and product safety.
Manufacturers placing cosmetic products on the EU and UK markets are legally required to compile and maintain a compliant PIF, containing detailed safety, formulation, and product information, which must be readily accessible to competent authorities upon request.
Cosmetic Product Safety Reports (CPSR)
Patient Guard delivers high-quality Cosmetic Product Safety Reports (CPSRs) to support regulatory compliance and consumer safety. Our expert assessors conduct thorough toxicological and exposure assessments, ensuring your products meet EU and UK requirements and are ready for market placement.
ISO 9001 Implementation
Looking to achieve ISO 9001 certification? Our expert ISO 9001 implementation services guide you through every step—from gap analysis to certification—ensuring your Quality Management System is compliant, efficient, and audit-ready. Patient Guard helps you achieve certification faster, with minimal disruption to your business.
ISO/IEC 27001 Implementation
Looking to achieve ISOIEC 27001 certification? Our expert ISO/IEC 27001 implementation services guide you through every step—from gap analysis to certification—ensuring your Information Security Management System is compliant, efficient, and audit-ready. Patient Guard helps you achieve certification faster, with minimal disruption to your business.
ISO 9001 Internal Auditing Service
Ensure your Quality Management System is fully compliant and audit-ready with our ISO 9001 internal audit services. Patient Guard delivers expert-led, independent audits to identify non-conformities, strengthen your processes, and support continual improvement—helping you pass certification and surveillance audits with confidence.
UK PPE Authorised Representative
Patient Guard provides expert UK Authorised Representative (UKAR) services for PPE manufacturers placing products on the Great Britain market. Acting as your UK-based legal representative, we ensure your products meet the requirements of the UK PPE Regulations and support your route to UKCA compliance. From technical documentation review and labelling verification to ongoing regulatory support and communication with UK authorities, our team ensures a smooth, compliant pathway to market. Whether you are launching new PPE products or expanding into the UK, we provide the expertise and reliability needed to maintain full regulatory compliance.
EU PPE Responsible Person
Patient Guard provides expert EU Responsible Person (EU RP) support for PPE manufacturers and importers placing products on the European market. We help ensure compliance with Regulation (EU) 2016/425 by supporting CE marking requirements, verifying technical documentation, and maintaining regulatory readiness. Acting as your EU-based regulatory partner, we facilitate communication with competent authorities and support ongoing post-market obligations. Whether you are entering the EU market or maintaining compliance across multiple products, our team delivers a reliable and efficient pathway to European market access.
ISO/IEC 27001 Internal Auditing Service
Patient Guard provides expert ISO 27001 internal auditing services to help organisations assess, maintain, and improve their Information Security Management System (ISMS). Our independent audits identify gaps, nonconformities, and areas for improvement, ensuring your system remains compliant with ISO/IEC 27001 requirements. From detailed audit reporting to practical corrective action support, we help you achieve certification readiness and maintain ongoing compliance. Whether preparing for initial certification or surveillance audits, our team delivers a structured and reliable approach to strengthening your information security framework.
CFR 21 Part 820 QSR Internal Auditing Service
Patient Guard provides expert CFR 21 Part 820 (QSR) internal auditing services to help medical device manufacturers assess, maintain, and improve their Quality Management System (QMS) in line with FDA requirements. Our independent audits identify quality system gaps, nonconformities, and areas of regulatory risk, ensuring your organisation remains compliant and inspection-ready. From detailed audit reporting to practical corrective action support, we help you strengthen your QMS and prepare for FDA inspections with confidence.
IVD CE Marking Technical Files (EU IVDR)
Patient Guard specializes in CE In Vitro Diagnostic (IVD) technical file creation and management, facilitating compliance with regulatory requirements for IVD manufacturers.
Our extensive expertise and knowledge of European regulations, ensure that technical files meet compliance requirements. From initial creation to ongoing management.
Patient Guard provides comprehensive support, enabling clients to navigate the complex regulatory landscape seamlessly while upholding product quality and safety standards.
Trust Patient Guard for expert guidance in technical file creation and management.
Performance Evaluation (EU IVDR)
Patient Guard’s Performance Evaluation services support IVD manufacturers in demonstrating scientific validity, analytical performance, and clinical performance in line with IVDR (EU) 2017/746.
We provide expert support in the preparation, review, and remediation of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER), ensuring your documentation is structured, evidence-based, and compliant with regulatory and Notified Body expectations.
Whether you are developing a new IVD, transitioning from IVDD to IVDR, or addressing compliance gaps, we help you build a clear and robust performance evaluation strategy to support CE marking and ongoing market access.
Scientific Validation Reports (EU IVDR)
Our Scientific Validation Report (SVR) services support IVD manufacturers in demonstrating the scientific validity of their devices in line with IVDR requirements. Patient Guard provides expert-led literature review, data analysis, and SVR development to ensure a clear and compliant association between the analyte and clinical condition, supporting successful CE marking and regulatory approval.
ISO 14971 Risk Management
Our ISO 14971 Risk Management services help medical device manufacturers identify, evaluate, control and monitor risks throughout the entire product lifecycle. From Risk Management Plans and hazard analyses to risk evaluation reports and post-market risk review, Patient Guard provides practical, compliant and audit-ready solutions aligned with EU MDR, UK MDR and ISO 14971 requirements
Post Market Performance Follow-up (PMPF) (EU IVDR)
Our Post-Market Performance Follow-up (PMPF) services support IVD manufacturers in maintaining ongoing IVDR compliance through proactive collection and evaluation of post-market performance data. Patient Guard provides expert PMPF planning, reporting, and performance evaluation support to help demonstrate continued scientific validity, analytical performance, and clinical performance throughout the device lifecycle.
Post Market Surveillance (PMS) for IVD Manufacturers (IVDR)
Our Post-Market Surveillance (PMS) services for IVDs help manufacturers maintain ongoing IVDR compliance through proactive monitoring of device safety, quality, and performance. Patient Guard provides expert support with PMS Plans, PMS Reports, PSURs, vigilance activities, and lifecycle compliance to ensure your IVD continues to meet regulatory and performance expectations after market placement.
Medical Device UKCA Mark Technical Files (UK MDR 2002)
Our UKCA Technical File Creation services support medical device manufacturers in preparing compliant technical documentation for the Great Britain market. Patient Guard provides expert support with technical file development, risk management, clinical evidence, labelling, and regulatory documentation to help manufacturers achieve UKCA compliance and Approved Body readiness with confidence.
IVD UKCA Mark Technical Files (UK MDR 2002)
Our UKCA Technical File Creation services support IVD manufacturers in preparing compliant technical documentation for the Great Britain market. Patient Guard provides expert support with technical file development, risk management, performance evaluation evidence, labelling, and regulatory documentation to help manufacturers achieve UKCA compliance and Approved Body readiness with confidence.
