Starodub can support the development and registration of your medical devices, such as class I to class III devices, including software, in vitro diagnostic and drug-device combination products worldwide.
We can also help you setting up and maintaining an ISO 13485 compliant quality management system. We do this efficiently with respect to time and cost.
The four pillars of our approach are to keep a helicopter view, look for potential opportunities, communicate risks, and find the optimal solution for issues at hand. This enables our clients to maintain good relationships with notified bodies and agencies worldwide.
We always start to challenge and discuss whether your product is a medical device/in-vitro diagnostic or combination product to provide you with the best and efficient support to achieve your goals. When the exact scope and budget for the project is clear, we'll dive into the details.
Services we can provide during the lifecycle of your device are:
- Qualify and classify your medical device against the applicable regulation
- Advise on global market access, the optimal regulatory strategy and execute this strategy in line with the chosen route of conformity
- Select assessment agencies such as Notified Bodies and establish a professional relationship with them
- Convert your EU registration files to EU MDR/IVDR compliant technical documentation
- Help you to understand your role and other roles, such as that of the Person Responsible for Regulatory Compliance (PRRC)
Design and development phase
- Advise on specifications and user test requirements
- Perform general safety and performance requirements check
- Author and/or review verification and validation protocols
- Execute verification and validation of product performance
- Author and/or review Technical Documentation
- Facilitate notification to agencies and assessment by notified bodies
- Perform the clinical/performance evaluation, risk management and plan post market activities
- Support appropriate change management when re-designing the medical device
- Perform compliance check on the company's quality management system
- Perform ISO/IEC compliance check; compliance with ISO 13485, ISO 14971, ISO 14155, IEC 62304, IEC 62366, etc.
- Perform gap analysis of processes and/or documents related to clinical/performance evaluation, risk management and post marketing
- Advise on how to prepare for on-site inspections by agencies and support your company during the actual inspection
- Support with regulatory intelligence
Planning and performing of clinical and performance evaluation with following development of Clinical/Performance evaluation plan (CEP/PEP) and Clinical/Performance evaluation report (CER/PER), including the conduction of literature search, in the compliance with relevant provisions of Regulation 2017/745 (MDR), Regulation 2017/746 (IVDR), MEDDEV 2.7/1 rev. 4 etc.
Planning and performing the risk management for the device according to the requirements of ISO 14971 followed by developing of Risk management plan (RMP), risk management report (RMR) and the entire Risk management file (RMF).
Planning the post market activities followed by developing of Post market surveillance plan (PMS plan), including planning of the post market clinical/performance follow-up activities in conjunction with clinical/performance evaluation procced with the development of PMCF/PMPF plans. Evaluating of data obtained by post market clinical/performance follow-up in a PMCF/PMPF evaluation report and summarizing all post market data in PMS report / Periodic safety update report (PSUR).
Starodub also provides training on MDR, IVDR and ISO 13485 or dedicated training on specific topics like design and development, marketing phase, post marketing phase, risk management, clinical/performance evaluation and clinical trials.
We develop customer based trainings so the training addresses your specific training needs.