Strategic guidance until CE marking
Initial GAP analysis and strategy set up
We consider involvement of HungaroTrial scientific, technical and regulatory experts early on the development key success factor. Understanding the design of the product from the perspective of regulators, health care, end-user and future market is essential to get value from our advisory. Comprehensive evaluation of available documentation in the light of strategic goals if where we start from to propose the regulatory path, select the Notified Body, determine elements for conformity assessments, plan the schedule, identifying and auditing critical subcontractors.
Technical documentation development
HungaroTrial will support establishing and maintaining submission ready Technical Documentation. We offer efficient combination of expert, medical writing, technical and administrative competence for:
- establishing, structuring, assembling and formatting Technical Documentation according to requirements.
- ongoing and comprehensive review for compliance to Essential Requirements
- review of clinical data and preparation of the Clinical Evaluation Report.
Pre-Audit before starting certification process
HungaroTrial special advantage is availability of Quality Management System professionals, personnel with the in depth knowledge of and working experience in evaluation of compliance with requirements and standards (e.g. MDD/MDR, ISO13485). HungaroTrial medical device Quality Management System specialists work together with Clients to determine pre-audit program for certification. Audit program may vary by scope and objectives , but is always focusing on the high-risk areas and opportunity to identify causes of issues for effective corrective actions and mitigations.
Support Technical Document Review Process
HungaroTrial applies streamlined and expedite procedure which ensures prompt, timely and qualified responses to requests arriving from Notified Bodies during the Technical Documentation Review. Qualified team members responsible for analyzing questions/issues, providing to the Client the appropriate corrective actions. Final review before submission ensures the answer to completely address the issues raised by Notified Body.
Support Conformity Assessment Process
HungaroTrial Regulatory Specialists will contribute to inspection readiness. They can be at your disposal to advise the preparation for audits by Notified Bodies. Our attendance at audit support communication with Notified Body auditors and facilitate the relevant responses. We built our expertise in the review and consultation for planning, implementation and evaluation of corrective and preventive actions that may include additional audits in areas with identified issues in order to ensure valid evaluation and actions directed towards root-cause.
Post Market Activities
After successful product launc and certification, HungaroTrial Expert Team will be at your disposal in order to ensure continuous compliance throughout the entire lifecycle of the launched product. We support further improvement activities with prompt regulatory service ensuring compliance in early stages, saving tiem and expenses for the customer.
Post Market Surveillance and Post Market Clinical Follow-up is a challenging activity, which also can be fully supported by Hungarotrial Regulatory Services, including PMCF Studies, and collecting and reviewing PMCF Clinical Data.