Chifa Arkhis

Specialist in Regulatory Affairs and quality assurance for medical devices and in vitro diagnostic devices. I bring my expertise to potential clients throughout the development cycle of their projects by supporting them in their regulatory strategies for market access, in the implementation of new regulations (EU Regulations 2017/745 and 2017/746), and in the optimization of their processes.

Main missions:

Evaluation and management of product changes (Change Control) in Europe for ureteral stents, urinary catheters, and collection systems:

Evaluation of product changes within the 'Product Support' team

Communication of regulatory impacts, documentary prerequisites, and authority decisions to project managers

Monitoring of deliverables with relevant teams (Design Control, Industrial, Quality, Marketing, Clinical, and Post-market Surveillance)

Notification and submission of changes to the Notified Body (NB) in Europe:

Preparation of change notifications and response to any requests from the NB (DNV Product Assurance AS)

Updating of technical documentation affected by changes according to EU Regulation 2017/745: risk analysis, usability, list of standards, biological evaluation report, clinical evaluation report, PMS and PSUR plans/reports, labeling, packaging, general safety and performance requirements, EU declaration of conformity

Submission for evaluation if necessary

Registration of product changes (Change Control) internationally:

Conducting regulatory impact analyses

Preparation of administrative and technical documentation for registrations, and support for export Regulatory Affairs teams.

Ancillary Missions:

Review and validation of product technical sheets, instructions for use, labels, boxes, and bags

Participation in regulatory and normative monitoring and coordination of impact analysis for the company (product, process, system)

Monitoring of REACH regulations: tracking ECHA updates, updating substance databases, evaluating substances, updating SDS and technical sheets, communicating with clients/users

Participation in audits within the Change Control process

Regulatory Role:

Gap analysis and creation of new templates for CE marking files according to Notified Body BSI guidelines

MDR/IVDR compliance of technical files according to EU Regulations 2017/745 and 2017/746 for sperm collection devices and biological sample collection devices

Updating of product risk analyses, periodic safety update reports (PSUR)

Compilation of design input data for the preparation of clinical and biological evaluation plans and reports

Analysis of gaps/updating of regulatory procedures

Registration of economic operators and devices on EUDAMED

Quality Role:

Participation in the ISO 13485 certification surveillance audit

Processing and follow-up of non-conformities and complaints, CAPAs

Management and follow-up of supplier/service provider data