At QA-1, we understand that navigating the path to ISO 13485:2015 certification can be daunting, especially for organizations facing challenges. One of our recent clients came to us with a pressing need for guidance. Their previous consultant had left them with significant gaps in their Quality Management System (QMS), resulting in over 70% of requirements unmet during the Stage 1 audit.
Referred to us for our expertise, we conducted a comprehensive review of their situation. Our experienced consultants identified key areas for improvement and crafted a tailored action plan. We believe in a collaborative approach, engaging with all staff members from day one to foster a culture of quality and compliance.
Thanks to our dedicated efforts, we successfully guided the client through the certification process, achieving ISO 13485:2015 certification from a European Notified Body within just four months.
If you're looking to enhance your QMS and achieve certification with confidence, we’re here to help you every step of the way. Let's work together to turn your certification goals into reality!
Case Study
