Collecting and managing clinical data.

Build strategic for clinical processes

Preparation and submission of clinical data/ documents.

Build training documents for clinical sites.

Help in managing and performing clinical experiments.

Data management.

Training program both for internal and external employees.

V&V – verification and validation processes.

document to support and monitor product approval verification.

Registration of devices per country – FDA (US); CE (UE); CFDA (China); AMAR (IL).

Build and implement regulatory strategy, including MDR, / IVDR notified body, etc.

Help managing and filling technical files.

Implementation of control and management systems.

Build QMS system.

Supporting in Risk analysis and management of decision-making processes.

Manage V&V processes as part of risk analysis for specific processes

Manage and control of procurement, production, product validation, lab tests, etc

Production control and management of correct procedures.

Management and employees training and evaluation for set targets.

Manage and way to control complains, corrective actions, way of reporting, and up to closing the complain and approval for continue of activity.

Manage and control labeling, assembly processes, quality processes, packing, delivery, distribution, etc.

Prepper and manage internal audits

Prepper and manage external audits

Prepper and manage audits for existing QMS, until receiving quality approvals.

Prepare and documents processes until receiving FDA, CE, CFDA, AMAR, etc.

Approval of suppliers, documentation, standards, audits, testing, etc

Manage and guidance until receiving certification of: ISO9001, ISO13485, ISO27001,

Prepper and mange all related processes until receiving regulatory approvals.

Prepare and guide the internal team how to manage, document and control external/ internal processes.

Prepare and manage risk analysis for different internal and external activities.

Prepare and manage protocols for IQ, PQ, OQ and until approval of supplier.

Manage breach of processes, documentation, corrective action, and until closing the breach and continue in routine work.

Risk management and control of processes and quality of activities/ services.

Prepare and mange requirement from internal/ external suppliers + monitor and approve fulfillment of requirements.

Prepare, manage and perform audits for critical suppliers will all issues related to production stages, clean rooms, machinery, packages, delivery of product, sampling testing, filling up relevant documentation, storage, etc.