Sandip More

Qa and Ra Consultant @Sushvin Consultancy Services

Hatfield, GB

Classification of Medical Device as per EU MDR 2017/745 Analysing and identifying gaps in MDD documents with respect to MDR 2017/745 and transition of those documents to establish compliance with EU MDR 2017/745 Responsible for maintaining QMS and ensuring compliance with ISO 13485 and to support associated standards (e.g, ISO 9001:2015, ISO10993-1:2008, ISO14971:2019, ISO 15223-1:2016) Writing, reviewing Risk Management Plan (RMP) and Risk Management report (RMR) for medical devices and their updating following changes to benefit-risk profile of medical devices in compliance with ISO 14971:2019 Writing responses to RFI’s/Deficiency Report received from notified bodies (NB) and following up on the remedial actions/tasks and provision of subsequent responses in timely manner Efficient management of regulatory Technical files to maintain CE Marking and EU and international regulatory requirements including MDD 93/42/EEC and MDR 2017/745. To include but not limited to:• Complaints/vigilance/recalls,• Post Market Surveillance and Clinical Follow Up• Clinical Evaluation• Risk Management• Liaising with the Regulatory Authorities• Completion of critical sub-contractor audits relating to ISO 13485 and CE marking of devices that could include internal, external and desktop. Labelling Remediation for all class I, II, products in compliance EU MDR 2017/745, ISO 15223-1:2016, ISO 60601-1, etc. Creation and updating of EU declaration of conformity Reviewing of Biological Evaluation Report (BER) to check compliance to latest standard ISO 10993-1:2018 Involved in Remediation of Clinical Evaluation Report (CER) as per MedDev 2.7.1 Rev 4 Creation of Design Verification and Validation Documents To develop and deliver strategy to meet the requirements of Medical Device Regulations Manage and optimise activities in line with the chosen strategy, regulatory requirements and agreed financial targets and resources

Bharti Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra, India

Bachelor’s Degree, Pharmacy

University of Greenwich

Master’s Degree, Formulation Science