Martin brings extensive global experience from working throughout the whole life-science value chain. His strong business acumen and diverse technical engineering background; Electronics, Software as a Medical Device, Mechanical Engineering and Materials science has guided him through 14 years of Medical Device and 10 Years of Pharmaceutical experience with 12 years in Hands-On Quality Assurance and Regulatory Affairs leadership roles for international organizations. With Sushvin Consultancy he channels his skill-set in helping companies efficiently realize their goals while meeting Quality Assurance and Regulatory Objectives that are harmonized with their target markets; European, USA and Rest of the Word.

Academic & Professional Qualifications

• PGD/MSc. Micro-electronics, Materials Science, Middlesex Polytechnic, London UK
• T.E.C. (B Sc.) Industrial Electronic Engineering, levels II, III, IV and V, Southend-on-Sea College of Technology
• MBA units: Accounting, Finance, Marketing: Herriot-Watt University of Edinburgh Scotland

Training, Quality Systems, & Specialties:

ISO 13485, MDR 2017/745, IVDR 2017/746, ISO 14971, IEC 62366, ISO 62304, ISO 9001, FDA 21 CFR 820, Change Management, Post Market Surveillance, GMP, GDocP, GDP 2013/C 343/01, GAMP, ICH Guidelines, etc.

With over 11 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 range of services to clients ranging from large and SME organisation. Along with being a Lead Auditor Aditya has being instrumental in developing regulatory strategies to register medical devices in the UK, EU and 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

With over 12 years of experience in the Medical Device and Pharmaceutical Industry, Sandip More hasdeveloped a broad knowledge base and deeper understanding of the regulatory requirements for registration of medical devices for the UK, EU, US, Middle East, South Asia and rest of the world (RoW) markets.
His experience spans across Quality and Regulatory compliance for Combination/BorderlineMedical Devices, SaMD including AI/ML, Active & Inactive Implantable Medical Devices and Custom made Devices.
He has provided his Quality and Regulatory expertise to wide range of clients ranging from SME’s to large manufacturing organisations with objective of making sure that their products meet highest of the standards for quality, safety and performance.
Along with having Quality and Re
gulatory expertise Sandip also has sound knowledge of Pharmacovigilance requirements for Medical Device and Pharmaceutical Products marketed in the UK and European markets. In his past experience he has worked at key responsible positions as Quality Assurance Manager and UK Responsible Person (RP).

Academic & Professional Qualifications

• Bachelor’s Degree (B. Pharm) : Shivaji University, Kolhapur, INDIA
• Master’s Degree (MSc.Formulation Science): University of Greenwich, UK

Training, Quality Systems, & Specialties:

• Medical Device Regulation (MDR 2017/745)
• In-vitro Diagnostic Medical Devices (IVDR 2017/746)
• UK Responsible Person (UK RP)
• ISO 13485 : 2016 Internal Auditor
• ISO 9001:2015 Lead Auditor
• UKCA Transition
• Post-market/Clinical Report Writing

Prashant has a deep and diverse knowledge of pharmaceutical industry backed by versatile experience in Quality Assurance & Regulatory Affairs. His experience gives him wide exposure to the markets of UK, Europe, America and Rest of the World (RoW).
His experience includes Quality and Regulatory compliance for Combination/Borderline Medical Devices, SaMD, IVD & IVF.
In his 12 + years experience in the Medical Device and Pharmaceutical Industry, he played a major role in varied departments and acquired key positions as, Deputy QPPV, Regulatory Manager, and QA & RA consultant.

Academic & Professional Qualifications

• Bachelor’s Degree (B. Pharm) : University of Pune, INDIA
• Master’s Degree (MSc.in Pharmaceutical Analysis): University of Strathclyde, UK

Training, Quality Systems, & Specialties:

• Medical Device Regulation (MDR 2017/745)
• In-vitro Diagnostic Medical Devices (IVDR 2017/746)
• UK Responsible Person (UK RP)
• ISO 13485 : 2016 Internal Auditor
• ISO 9001:2015 Lead Auditor
• UKCA Transition
• Post-market/Clinical Report Writing