Greenlight

Rook Quality Systems specializes in quality and regulatory strategies consulting for medical device companies.

Designer and manufacturer of therapeutic and diagnostic medical devices serving clients of all sizes ranging from startups seeking seed funding to established Fortune 500 companies. The company specializes in cybersecurity, device development, test systems and medical device manufacturing and offers expertise in software, usability, cybersecurity, electrical and mechanical development for medical equipment, thereby enabling clients to transform their IP into a safe and secure product that will change lives for a better world.

Operator of a regulatory requirements consulting company intended to advise clients on how best to meet the regulatory requirements of the MHRA, FDA, and notified bodies. The company offers consultancy services ranging from design, implementation, and maintenance of quality management systems, preparation of technical files for regulatory approvals, part-time and interim management support, and auditing both internal and external, thereby providing clients with a risk-based approach to meeting their quality and regulatory needs which is cost-effective with regards to assisting with the development approval, manufacture, storage, and distribution of their products.