Regulatory support & Risk assessment

Thanks to the high level of expertise of our specialist partners, we are able to offer qualified support in regulatory fields of medical devices:

• providing a full assistance in planning the best path for the certification of any given medical device;
• supporting in technical and pre-clinical data collection needed for regulatory purposes;
• developing a sound regulatory approach to getting clearance in many different countries: from Russia, the US, China, India and many more.

CE MARKING

• Audit & Consulting
• Technical File Preparation
• Administrative Procedures Management Submission & follow up

OBL PROCEDURES

• Audit & Consulting
• Administrative Procedures Management
• OBL submission & follow up

ISO13485 CERTIFICATIONS

• Audit & consulting
• Quality System Documentation Preparation Support during Inspections

Risk assessment

In accordance with ISO 14971:2007, the biological assessment of any medical material or device intended for use in humans shall be part of a structured biological assessment plan as part of a risk management process. This risk management process involves identifying biological hazards, estimating the associated biological hazards and determining their acceptability.