CS Lifesciences

medical devices

About

CS Lifesciences is a consultancy firm based in Dublin, Ireland, specializing in regulatory compliance, quality assurance, and clinical research services for medical device and in vitro diagnostic (IVD) innovators. The company partners with clients to navigate complex regulatory environments, including FDA, CE marking, and MHRA, to facilitate product development and market entry. Their collaborative approach involves embedding with client teams to provide tailored support throughout the product lifecycle. The firm offers expertise in designing and maintaining quality management systems (QMS), preparing regulatory submissions, and managing compliance across various sectors, including biological products and stem cell industries. CS Lifesciences serves a diverse clientele, from startups to multinational corporations, ensuring flexibility in their consultancy services. Recently acquired by Abingdon Health plc, the company has secured significant contracts, enhancing its capabilities in the international IVD and medical device markets. Edwin Lindsay leads the firm as Principal Consultant and Managing Director.

Technologies

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Keywords

quality management system medical device consultancy mdr regulatory approvals ivdr ivds fda ukrp euar regulatory 510k ce marking ukca pma clinical trials risk management design control & design history files iso 13485 21 cfr part 820 responsible person validation and verification ivd compliance regulatory strategy development training and mentoring regulatory inspection support gmp compliance healthcare consulting risk assessment

Location

Glasgow, Scotland, United Kingdom

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