Medical Device Regulatory and Quality Services from Patient Guard are industry leading. Patient Guard has developed into a leading medical device and IVD regulatory consultancy and has been trading since 2017. Our experts have over 20 years experience in medical device and IVD regulation and Quality Assurance. We work with all sizes of medical device organisations from start-ups to large corporate. Being an established medical device 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 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 consultancy services, specializing in guiding healthcare organizations through the intricate landscape of medical technology. With a team of seasoned professionals, Patient Guard provides comprehensive assistance in regulatory compliance, product development, quality management, and risk assessment. Their 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.
Patient Guard’s Post-Market Surveillance and 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) requirements, Patient Guard assists clients in appointing qualified PRRCs, establishing robust post-market surveillance systems, and conducting vigilance reporting. By partnering with Patient Guard, manufacturers can confidently navigate the complexities of post-market compliance, safeguarding product integrity and ensuring continued regulatory adherence.
QMS implementation Services
Patient Guard’s Quality Management System (QMS) implementation service is tailored to help medical device manufacturers establish and maintain robust quality systems. Leveraging 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.
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.
As an MHRA registered Responsible Person, Patient Guard is well placed to support you in registering your Medical Devices on the UK market.
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. Representative, Patient Guard is well placed to support you in registering your Medical Devices on the EU market.
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 every 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.
Internal Auditing Service
Patient Guard offers Internal Audit services tailored to medical device manufacturers, assisting in the assessment and improvement of quality management systems. Their expert auditors conduct thorough evaluations to ensure compliance with regulatory standards such as ISO 13485. Through meticulous review and analysis, Patient Guard identifies 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.
CE/UKCA Technical Files
Patient Guard specializes in CE and UKCA technical file creation and management, facilitating compliance with regulatory requirements for medical device manufacturers. Leveraging extensive expertise and thorough understanding of European and UK regulations, they meticulously compile and maintain technical documentation, ensuring alignment with applicable standards and guidelines. 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.
Patient Guard offers comprehensive clinical evaluation and management services tailored to medical device manufacturers. With a focus on regulatory compliance and patient safety, their experienced team conducts rigorous assessments to gather and analyze clinical data. From designing clinical trials to interpreting results and compiling reports, Patient Guard guides clients through every 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.
Patient Guard provides expert Post-Market Clinical Follow-up (PMCF) services to medical device manufacturers, ensuring ongoing assessment of device safety and performance post-market release. With a focus on compliance with regulatory requirements, their 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.
Vigilance & PMS
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.
Cosmetics Responsible Person
Patient Guard extends its expertise to include a Cosmetics Responsible Person service, aiding manufacturers in adhering to regulatory standards for cosmetic products. As the designated Responsible Person, Patient Guard assists in fulfilling legal obligations, ensuring product safety, and facilitating compliance with regulations like the EU Cosmetic Regulation. By leveraging their knowledge and experience, Patient Guard supports manufacturers in navigating the complexities of the cosmetics market, safeguarding consumer well-being, and maintaining regulatory compliance. Trust Patient Guard for reliable Cosmetics Responsible Person services.