EU Medical Device Regulatory Consultancy Services
As the healthcare landscape evolves, ensuring the safety, efficacy, and compliance of medical devices in the European market has become increasingly complex.
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.
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.
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.
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.
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.
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.
CE/UKCA Technical Files
Patient Guard specializes in CE and UKCA medical device technical file creation and management, facilitating compliance with regulatory requirements for medical device manufacturers.
Our extensive expertise and knowledge of European and UK 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.
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
As a designated Cosmetics Responsible Person, Patient Guard ensures compliance with the legal requirements of the EU and UK cosmetic regulations, ensuring product safety.
Manufacturers who do not have a registered business in the EU are legally required to have a Cosmetics Responsible Person to register their products on the EU CPNP database.
Manufacturers who do not have a registered business in the UK are legally required to have a Cosmetics Responsible Person to register their products on the UK OPSS database.
