At Documedex, we are dedicated to guiding medical device manufacturers and developers through the complex world of regulatory compliance. With a deep understanding of the global medical device regulatory landscape, we help you navigate the stringent requirements to bring your products to market efficiently and safely.

Our team consists of seasoned technical experts, clinicians, experienced lead auditors, CE certification assessors, and qualified regulatory affairs professionals who have worked with Notified Bodies and medical device manufacturers for over 20 years. They bring extensive experience in regulatory affairs, technical documentation requirements, quality management systems, clinical evaluation, and risk management.

Our Mission
We are committed to empowering companies by offering tailored, expert-driven solutions that not only ensure compliance but also foster innovation and growth in the medical device industry. Our services include consulting in:

• Regulatory Pathway
• Technical Documentation according to EU MDR 2017/745
• CE Certification (EU MDR 2017/745)
• ISO 13485 & EU MDR Quality Management System
• MDSAP (Medical Device Single Audit Program - Australia/ USA/ Japan/ Brazil/ Canada)
• Clinical Evaluation and Clinical Trial
• Risk Management according to ISO 14971
• Usability Study (IEC 62366-1 / EN 62366-1)
• Software Validation (IEC 62304 - SaMD)
• Registration of medical device globally (EUDAMED, ARTG, etc)
• Providing templates relevant to Technical Documentation and Quality management System (ISO 13485, EU MDR, MDSAP, etc)