Adnan Ashfaq
Founder Director @Simplimedica Ltd
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WORK HISTORY
Founder Director @Simplimedica Ltd
Edinburgh/ Leeds, GB
Recently involved in -1) Gap Assessments for MDR for several companies, and writing up CE technical files for Class I and Class IIa and IIb2) Putting in ISO 13485: 2016 QMS3) CSV Validation work4) Design Control and Risk Management work5) Assisting startups as QA/RA consultant 6) SaMD expertise with 62304 knowledgeworked on projects with several Medical Device companies involving:1) Packaging Validations for Wound Closure Surgical Solutions2) Labelling Systems for the Pharmaceutical Industry3) Plastics for Medical Device4) Design Matrices and Technical File Remediation5) Validation Overhaul for major Medical Device company6) Regulatory Work7) Full Risk Management for new products8) FDA Design History File Remediation Work (Orthopaedics Implants)9) Auditing suppliers, Internal Audit (IRCA certified Lead Quality Auditor ISO 13•••10) Writing entire Quality Management Systems for start ups11) Assisting IVD start up company for CE marking and ISO certification12) Gap Analysis for IVDR and MDR Implementation13) Set up GMP QMS for 2 companies including all validation14) IVDR and MDR transition work, Project Management
EDUCATION
Coventry University
Manufacturing Systems, engineering
LRQA
IVDR - 2 Day Implementation course
LRQA
MDR 2 Day Implementation course
BSI
MDSAP 2 Day Implementation course
IRCA
Lead Auditor Certified by IRCA for ISO 13485 and 9001
SKILLS
ABOUT ADNAN ASHFAQ
I am a leading Quality, Regulatory & Validation Specialist at Simplimedica Ltd, a boutique consultancy established in 2011. With over 25 years of experience in the medical device, biotech, and pharmaceutical industries, I bring a wealth of technical proficiency and regulatory acumen to my clients.Expertise & ServicesI lead Simplimedica with a mission to simplify complex regulatory landscapes for medical device innovators. The firm offers end‑to‑end support—from designing compliant Quality Management Systems (including ISO 13485), CE marking, UKCA, FDA submissions, and IVD compliance to risk management, design control, validation strategies, audit readiness, and regulatory roadmap development Strategic VisionI am passionate about guiding early-stage startups and multinational teams alike through the “labyrinth of regulations,” enabling them not just to enter, but stay in regulated markets—especially amid tightening European regulations.Thought Leadership & Industry ContributionsBeyond consultancy, I am a proactive thought leader and educator. I have featured on several influential podcasts—including the *Global Medical Device Podcast*—where I break down vital topics like regulatory roadmaps (strategic planning for time, cost, and resourcing), the importance of precise intended use statements, IEC 62304 for software, process validation, and navigating global regulatory landscapes.Client-Centric ApproachClients consistently highlight my depth of knowledge, responsiveness, and ability to demystify highly technical subjects. Whether leading gap analyses, ISO transitions (e.g, ISO13485:2016), audit remediation, or interim quality management, he delivers value with clarity and strategic insight Why I Stand OutMy ability to translate complex regulatory requirements into actionable roadmaps and quality strategies makes me a trusted partner for innovators worldwide. I bring not only expertise, but genuine collaboration.
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