01. THE CHALLENGE
A state-of-the-art ophthalmology company specializing in diabetic retinopathy engaged Critical Software to certify its medical device development processes in accordance with ISO 9001:2008 and ISO 13485 standards. Device certification was pursued under Class IIa requirements, as defined by the European Council Directive 2007/47/EC (Medical Devices Directive).
02. THE SOLUTION
As an ISO 13485-certified organization, Critical Software leveraged its expertise to conduct a comprehensive gap analysis of the client’s Quality Management System (QMS). Based on this assessment, we implemented the necessary processes and developed supporting documentation to ensure compliance with applicable regulations.
In parallel, we defined the overall project structure and supported both the development and verification & validation (V&V) teams in carrying out all activities required to meet the certification class requirements.
Working closely with the client’s in-house development team, we contributed across the entire medical device development lifecycle, ensuring the QMS was aligned with EU regulatory requirements.
Our work also included close collaboration with certification authorities and on-site audit support, providing the necessary safety and compliance evidence to enable the device to achieve CE marking.
03. THE RESULTS
This engagement resulted in a fully certified QMS aligned with all relevant standards, strengthening the reliability of development, verification, and validation processes.
The successful QMS implementation, combined with rigorous adherence to established policies and procedures by the development and V&V teams, enabled the device to achieve Class IIa certification.
Critical Software’s ISO 13485 consultancy and expertise in working with national certification authorities minimized audit risks and ensured that development processes remained safe, efficient, and optimized for faster time-to-market.
04. THE TECHNOLOGY
Gap analysis
Document templates
Project quality plans
Verification & validation expertise
Documentation aligned with EU standards
Audit support and compliance assurance