Aditya Kulkarni


With over 9 years in the Medical Device and Pharmaceutical industries, Aditya Kulkarni has a broad and deep knowledge of the MHRA and EU-regulated industry. His experience is in Quality and Regulatory for Combination Products, Woundcare, SaMD, Orthopaedics, active & inactive medical devices, and custom-made devices. He has provided a broad scope of services to clients ranging from large and SME organizations. Along with being a Lead Auditor, Aditya has been instrumental in developing regulatory strategies to register medical devices in the UK, EU, and the rest of the world.

Academic & Professional Qualifications:
  • Pharm: University of Pune, INDIA
  • MSc in Formulation Science: University of Greenwich, UK
  • MBA: The PowerMBA
Training, Quality Systems, & Specialties:
  • Medical Device Regulation (MDR 2017/745)
  • UK Responsible Person  
  • ISO 13485:2016 Internal Auditor
  • ISO 9001:2015 Lead Auditor
  • MDR Remediation 
  • DHF Remediation
  • UKCA Transition
  • CER Writing