About Sushvin Consultancy

Martin brings extensive global experience from working throughout the entire life-science value chain. His strong business acumen and diverse technical engineering background, including Electronics, Software as a Medical Device, Mechanical Engineering, and Materials Science, have guided him through 14 years in the Medical Device industry and 10 years in Pharmaceuticals. With 12 years in hands-on Quality Assurance and Regulatory Affairs leadership roles for international organizations, Martin is a seasoned expert.

At Sushvin Consultancy, Martin channels his skill set to help companies efficiently realize their goals while meeting Quality Assurance and Regulatory Objectives that are harmonized with their target markets, including Europe, the USA, and the rest of the world.

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, Heriot-Watt University, 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

Martin’s extensive qualifications and hands-on experience make him an invaluable asset to our team and clients. His expertise ensures that companies can navigate the complex regulatory landscape with confidence and efficiency.

With over 11 years in the Medical Device and Pharmaceutical industries, Aditya Kulkarni possesses broad and deep knowledge of the MHRA and EU regulated industry. His expertise spans Quality and Regulatory Affairs for Combination Products, Wound Care, Software as a Medical Device (SaMD), Orthopaedics, Active & Inactive Medical Devices, and Custom-Made Devices. Aditya has provided a wide range of services to clients, from large corporations to SMEs. As a Lead Auditor, he has been instrumental

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

Aditya’s extensive qualifications and hands-on experience make him an invaluable asset to our team and clients. His expertise ensures that companies can navigate the complex regulatory landscape with confidence and efficiency.

With over 12 years of experience in the Medical Device and Pharmaceutical Industry, Sandip More has developed a broad knowledge base and a deep understanding of the regulatory requirements for registering medical devices in the UK, EU, US, Middle East, South Asia, and the rest of the world (RoW) markets.

His expertise spans Quality and Regulatory compliance for Combination/Borderline Medical Devices, SaMD including AI/ML, Active & Inactive Implantable Medical Devices, and Custom-Made Devices. Sandip has provided his Quality and Regulatory expertise to a wide range of clients, from SMEs to large manufacturing organizations, ensuring their products meet the highest standards for quality, safety, and performance.

In addition to his Quality and Regulatory expertise, Sandip has sound knowledge of Pharmacovigilance requirements for Medical Device and Pharmaceutical Products marketed in the UK and European markets. In his past roles, he has held key positions such 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

Sandip’s extensive qualifications and hands-on experience make him an invaluable asset to our team and clients. His expertise ensures that companies can navigate the complex regulatory landscape with confidence and efficiency.

Prashant has a deep and diverse knowledge of the pharmaceutical industry, backed by versatile experience in Quality Assurance & Regulatory Affairs. His extensive experience gives him wide exposure to the markets of the UK, Europe, America, and the Rest of the World (RoW).

His expertise includes Quality and Regulatory compliance for Combination/Borderline Medical Devices, SaMD, IVD, and IVF. In his 12+ years in the Medical Device and Pharmaceutical Industry, Prashant has played major roles in various departments and held key positions such 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

Prashant’s extensive qualifications and hands-on experience make him an invaluable asset to our team and clients. His expertise ensures that companies can navigate the complex regulatory landscape with confidence and efficiency.