COMPLIANCE SOLUTIONS (LIFE SCIENCES) LIMITED

CS Lifesciences is a consultancy company based in the UK, Ireland and USA, specializing in Quality, Clinical, and Regulatory needs for Manufacturers of Medical Devices, In Vitro Diagnostics (IVD) and Clinical Diagnostics. They offer end-to-end support including product development, quality management systems, clinical trials, regulatory submissions, and post-market support. Their services include, but are not limited to: Clinical Evaluation, 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, FDA Pre-IDE Meetings, FDA Presub Meetings, 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. Compliance Solutions also has experience within the life science industry (including blood establishments) advising on how to best meet the regulatory requirements of the MHRA, FDA, Notified Bodies and ICH, for the one-man start up to multi-national companies.