We are a team of dedicated professionals with a depth of expertise to support our clients through the maze of international compliance in safety critical projects from concept through to delivery.
Our own personal commitment to ongoing training and development ensures we are continually developing our core strengths and experience to provide industry leading consultancy to our clients.
Alastair Walker – Owner/Consultant
Alastair is an engineering consultant with more than 25 years’ development experience in the medical, automotive and aviation industries. He has worked on a diverse range of safety related products including ECG systems, cryotherapy systems, electrical muscle stimulators, aviation transponders and comms radios, electric motorbikes, in-wheel motors ASIL-D and automotive battery management systems. Alastair has extensive knowledge of developing embedded systems in safety-related industries.
Alison Young – Functional Safety Consultant
Alison has 14 years’ automotive industry experience, and for the last 5 years has been responsible for ensuring the functional safety of automotive microcontrollers. She has been involved in the development of microcontrollers for a variety of automotive applications and has extensive experience of delivering the work products required by ISO 26262, including requirements capture, safety plan, safety case, FMEDA and customer facing safety documentation.
Sharon McKechnie – Medical Device Compliance Consultant
Sharon has over 17 years’ reliability, risk, regulatory and quality management experience within the medical device industry and has worked on a diverse range of medical devices such as Left Ventricle Assist Devices (LVAD), Implanted Cochlear products, Ophthalmic Retinal Imaging, Electrocardiograph Monitors, Ambulatory Blood Pressure Monitors, Anaesthesia equipment and Software as a Medical Device.
Sharon’s expertise includes reliability engineering & dependability analysis, quantitative and qualitative risk analyses for hardware, software and firmware (such as fault tree analysis, hazard analysis, design & process FMEA) and system requirements management including design & technical reviews.
In addition, Sharon is a NAMSA trained biological safety specialist and a registered IRCA Auditor with experience of auditing and implementing Quality Management Systems under ISO 13485, ISO 9001, FDA 21 CFR 820, Medical Device Directive and recently Medical Device Regulation (MDR) and Medical Device Single Auditing Program (MDSAP).
Linda Stein – Marketing Manager
Linda is a sales & marketing professional with experience across several industry sectors including Medical, Automotive, IT, Oil & Gas and Engineering. She holds responsibility for all marketing communications, events, web and social media activities.