Creative solutions, creative results.
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.
Ascend QA is a Cambridge based test house and QA consultancy, specialising in solutions for MedTech, Wireless, FinTech and Aerospace. Ascend QA work with us to develop automation frameworks, test tools, DevOps infrastructure and compliance strategies for our mutual clients. Whether working with scrappy start-ups, or at enterprise level, Ascend QA is a proven leader in the field.
Learn MoreChairman and Founding Partner
A former academic who has consulted around the globe for companies such as Roche, Genentech, and a host of consulting companies in Cambridge. He has over twenty-five years of research and development experience that has involved managing development teams, architecting, designing, and implementing Medical Devices and Systems (including Digital Health and Software as a Medical Device (SaMD)).
Senior Consultant
A versatile engineer with over 25 years of experience in product and software development within a variety of technology sectors. Developed products include Medical Devices and Systems, Cybersecurity, Data Communications, Smart Metering, IoT, Maritime, and Automotive Electronics. He has held positions ranging from Developer to Head of Engineering for a variety of companies including Silicon Valley start-ups and Major Pharmaceutical companies.