Get your CE marking
Embark on a clear path to CE Certification under MDR 2017/745 with our expert support. We're here to help you overcome the complexities of compliance, ensuring your medical device meets all regulatory benchmarks with precision and efficiency.
The challenge
The primary hurdle many face in achieving CE Marking under MDR 2017/745 is the misalignment between the established Quality Management System (QMS) and actual internal practices, often tailored solely to meet regulatory demands. Additionally, the technical documentation must not only comply with stringent regulatory standards but also reflect the agile development practices prevalent in medical device software engineering, ensuring a seamless integration of regulatory compliance with dynamic development cycles.
Our solution
Harness our deep expertise in the MDR 2017/745, IEC 62304 and ISO 13485 standards, among others, to ensure your Quality Management System (QMS) and your Software as Medical Device's (SaMD) documentation are fully compliant.
Our solutions are meticulously designed to seamlessly integrate regulatory compliance within your internal operations, ensuring a smooth adaptation to regulatory standards without disrupting your existing workflows. Here's how we address this:
- Customized compliance strategies: Our drafting and guidance services are crafted to harmonize with your unique operational processes, making regulatory compliance a seamless extension of your business practices.
- Regulatory training: To ensure enduring compliance and internal competence, we offer specialized training sessions on key regulatory themes, equipping your team with the knowledge to navigate the regulatory landscape confidently.
- Adaptive solutions: Whether it's comprehensive drafting of technical files and QMS or providing expert coaching with flexible complete templates, our approach is always aligned with your specific needs and internal practices.