Background
Dr. Hamidreza Alidousti has over 15 years of experience in the medical device industry, spanning design, research and development, commercialization of innovative, cutting-edge technologies, and regulatory affairs. This includes more than 5 years of in-depth expertise in medical device regulations, with direct involvement in the assessment of high-risk devices as a subject matter expert, as well as leading and managing teams within a Notified Body. His experience encompasses both manufacturer and certification body perspectives.
Education
Dr. Alidousti received his PhD from the University of Southampton, a Russell Group university, with a focus on orthopedic bioengineering and computational biomechanics. He earned his Master of Engineering in Medical Engineering from Queen Mary University of London. Following his formal education, he also completed postdoctoral research projects at Imperial College London.
Experience
Prior to joining MCRA in April 2025, Dr Alidousti led and managed the Orthopedic Team at the Notified Body SGS, where his team was responsible for technical documentation reviews under both the EU MDR and UK MDR, supporting CE and UKCA certifications. In this role, he trained, mentored, and supervised technical file reviewers; developed technical and regulatory training programs; and managed the workflow of complex projects involving all aspects of regulatory review. This included coordination among clinical, technical, biocompatibility, sterilization, and horizontal MDR code experts (e.g., animal tissue, absorbable materials, measuring functions, etc.). He also provided strategic guidance on documentation sampling approaches, device categorization according to MDN and EMDN codes, estimation of review durations, and cost-effective review strategies. In addition, he liaised directly with clients to resolve complex regulatory issues and maintained a proactive screening system to remain aligned with evolving regulatory requirements.
Before taking on this leadership position, Dr Alidousti conducted extensive technical and clinical reviews for both EU MDR and MDD certifications, amassing over 3,800 hours of technical documentation reviews. His work encompassed Class III, IIb, and IIa devices and instruments, addressing all components of the technical documentation, including Clinical Evaluation Reports, design validation and verification, biocompatibility, risk management, packaging, and labelling.
Prior to his work at a Notified Body, Dr. Alidousti was awarded two enterprise fellowships to support the fundraising and commercialization of innovative and cutting-edge medical devices.
Earlier in his career, Dr. Alidousti was part of a multidisciplinary translational research team at Imperial College London, where he worked on the development of an innovative joint replacement system. This role involved close collaboration with surgical teams and included the full spectrum of implant design—from initial concept through to final industrial manufacturing—along with comprehensive computational modelling, mechanical and cadaveric testing, preparation of technical documentation, risk management files, and clinical development plans.
Overview
Dr. Alidousti is an expert in the medical device industry, with over 15 years of experience spanning design, development, commercialization, and regulatory affairs. He specializes in regulatory strategies for European market entry under both EU MDR and UK MDR frameworks. His expertise includes the development of compliant technical documentation (TD), identification of appropriate conformity assessment routes, leveraging equivalence pathways, and applying provisions such as EU MDR Article 61(10) and UK MDR Annex X 1.1(d) to minimize the need for additional clinical investigations by utilizing existing clinical data whenever possible. Dr. Alidousti also supports clients in designing robust clinical studies to generate reliable safety and performance data and employs product-specific standards or innovative methodologies to demonstrate technical performance. His approach emphasizes streamlined, cost-effective regulatory pathways and strategies without compromising compliance.