Medical devices and In vitro Diagnostic

The European regulatory landscape for medical devices has been increasing in complexity, creating greater challenges that demand an immediate solution to maintain or gain access to the European markets. BCCC collaborates with MedTech companies, providing guidance on navigating the regulatory landscape to ensure the placement and maintenance of medical devices and in vitro diagnostics in the EU market through the following Regulatory Services.:

• Support in preparing technical documentation and post-market technical documentation.
• Developing a roadmap for CE marking and regulatory strategy.
• Creating and conducting clinical evaluation and performance evaluation processes.
• Facilitating communication with notified bodies, competent authorities, and economic operators.
• Assisting in the transition to MDR/IVDR