Richard Cook

Richard Cook is a software and systems engineering expert who works on all phases of the software life cycle. His experience ranges from R&D level concept design of prototypes to production release and service/maintenance. His consulting services include: software risk analysis, including compliance with ISO 14971 and IEC 62304; software architecture and development; development of software SOPs which adhere to IEC 62304; software documentation; software verification and validation testing; IEC 62304 audits; and regulatory training for software teams. Mr. Cook also offers consulting on cybersecurity documentation and testing, including adherence to AAMI TIR57, planning, support, risk analysis, testing, maintenance, and auditing of software systems for cybersecurity concerns to ensure compliance with recent FDA Guidance.