Team
Aditya Kulkarni
Consultant
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