CS Lifesciences are your one stop shop consultancy company based in the UK, Ireland and USA that can meet all your Quality, Clinical and Regulatory Needs. Our knowledge and experience make us uniquely qualified to represent and support Manufacturers of Medical Devices, In Vitro Diagnostics (IVD) and Clinical Diagnostics. End-to-End support, from development of your product, to establishing your quality management system, managing your clinical trials, regulatory submissions and post market support. We understand you have a business to run, and at CS Lifesciences we balance that with delivering your Quality, Clinical and Regulatory requirements. Whether navigating the FDA processes, obtaining CE marks or acting as your EU or UK Authorised Representative, CS Lifesciences will take you through the process in a way that minimizes time and resources – while meeting all your needs. Our hands-on practical approach, is based on years of working with a vast range of different types and sizes of companies, meaning you get the best advice and clearly identified actions which lead to successful approval of your products. Compliance Solutions understand that your business will often have a varying requirement for consultancy support to meet the fluctuating needs of particular projects and activities. That is why we provide you with a flexible approach that is tailored to your requirements. End-to-End support from development through quality management systems, regulatory submissions and clinical trials, with services covering, but not limited to: · Clinical Evaluation, including CEP/CER. · Periodic Safety Update Reports (PSUR)- · Post Market Performance Follow-Up (PMPF)Report · Summary of Safety and Clinical Performance (SSCP) · Performance Evaluation Plan and Reports · Biological Safety Evaluation (ISO 10993) - BER/BEP · Toxicological Evaluation · Sterilization assessment and support · UKCA & CE Marking · MDR Support · IVDR Support · Technical File Creation/Remediation, including supporting Documentation. · Perform gap analysis of Technical File or Design Dossiers · FDA Pre-IDE Meetings, including documentation and meeting participation · FDA Presub Meetings, including documentation and meeting participation · FDA Breakthrough and Safer Technologies Program (SteP) for Medical Devices · FDA Pre-market submissions: 510(k), PMA, HDE · Quality Management Systems (ISO 13485 & 21 CFR Part 820) Support · Training/ Customized training · Design Control and Development · Usability · Packaging/Transportation/Stability/Shelf Life · Risk Management · Regulatory Submissions · Software · Software as Medical Device (SaMD) · Electrical and EMC Safety · Clinical Trials · PRRC Support · UKRP/European Authorised Representative/US Agent Services