CE mark your software
Embark on a clear path to CE Certification under Regulation (EU) 2017/745 (MDR) with the support of our experts. We are here to help you navigate the complexities of compliance, ensuring your medical device meets all regulatory criteria with precision and efficiency.
An alignment issue between quality and practice
The main obstacle many face in obtaining CE marking under Regulation (EU) 2017/745 is the lack of alignment between the established Quality Management System (QMS) and actual internal practices, often designed solely to meet regulatory requirements.
Technical documentation must not only comply with strict regulatory standards but also reflect the agile development practices prevalent in medical device software development.
Compliance integrated into your operations
Let our deep expertise in MDR 2017/745, IEC 62304, and ISO 13485 standards, among others, guide you to ensure that your Quality Management System (QMS) and Software as a Medical Device (SaMD) documentation are fully compliant.
Tailored compliance strategies
Our writing and advisory services are designed to align with your unique operational processes, making regulatory compliance a natural extension of your business practices.
Regulatory training
To ensure lasting compliance and internal competence, we offer specialized training sessions on key regulatory topics, equipping your team with the knowledge needed to navigate the regulatory landscape with confidence.
Adaptive solutions
Whether it involves complete drafting of technical files and QMS or providing expert coaching with flexible comprehensive templates, our approach is always aligned with your specific needs and internal practices.
Let's talk about your device.
30 minutes to scope your needs.
GMED certifiedfor QMS internal audit
BPI Franceexperts