We offer a range of Consulting Services to support clients in developing Medical Devices and Systems whether they be purely software (SaMD) or a combination of software and hardware (SaMD, SiMD). All our consultants have been through the "concept through to Regulatory Submission and approval” pathway on multiple projects for both the FDA and EU. The services we offer include: • Medical Devices and Systems Development (including software and hardware) from concept through to Regulatory Submission and approval. • Risk Management for Medical Devices and Systems. • Cybersecurity for Medical Devices and Systems, including Consumer Product Cybersecurity. • Software Risk Management for Medical Devices and Systems. Reviewing DHF documents for IEC 62304 and IEC 82304. Managing, Leading, and Mentoring Engineers.