What's included

• 1 week

  I specialize in guiding medical device companies through the entire regulatory and compliance process to ensure their products meet all necessary standards for market approval. From initial concept to final market release, I provide comprehensive support in navigating complex regulations such as ISO 13485, EU MDR, and FDA requirements. My services include: Regulatory Strategy Development: Crafting tailored strategies to ensure compliance with global regulations. Technical Documentation: Preparing and organizing essential documentation, including Technical Files and Design Dossier, to meet regulatory standards. Testing and Validation: Identifying and overseeing the necessary tests (e.g., biocompatibility, usability, electrical safety) to ensure device safety and efficacy. Quality Management Systems (QMS): Implementing and maintaining ISO 13485-compliant QMS to streamline processes and ensure continuous compliance. Risk Management: Conducting risk assessments and creating risk management plans in line with ISO 14971. Post-Market Surveillance: Setting up systems for post-market monitoring and reporting to ensure ongoing compliance and product improvement. Whether you're developing a new medical device or preparing an existing product for market entry, I can help you navigate the regulatory landscape efficiently and effectively. Let’s work together to bring your innovative medical solutions to market with confidence!