Our regulatory services for IVD products include:
  • 1. Regulatory strategy development: We assist you in developing a strategic regulatory plan, taking into consideration different market requirements and optimizing the pathway for product approvals.
  • 2. Regulatory submissions and document preparation: We support you in the preparation of the necessary technical documentation and submissions to relevant regulatory authorities, such as the United States FDA, the European Union's IVDR, and other global agencies.
  • 3. Classification and registration: We help you determine the appropriate classification for your IVD products, and guide you through the registration process in various markets.
  • 4. Clinical study support: Our team of experts will help you design and execute clinical studies necessary for supporting regulatory submissions and product claims, ensuring compliance with regulatory requirements and ethical guidelines.
  • 5. Risk management: We provide guidance on the identification, assessment, and mitigation of risks associated with your IVD products, in accordance with standards such as ISO 14971.
  • 6. Post-market surveillance and vigilance: We assist you in monitoring the performance and safety of your IVD products once they are on the market, ensuring continued compliance with regulatory requirements and addressing any potential safety concerns.
Our regulatory services are designed to support your success in the IVD industry by ensuring that your products meet the highest quality and safety standards while optimizing the approval process across different markets. Please do not hesitate to contact us for further information or to discuss the specific needs of your IVD product development project. We look forward to partnering with you on this journey.
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DARAPY MedTech Consulting is a consulting company specialized in IVDs. We provide a wide range of services in Product Development (Immuno and Molecular Diagnostics), Regulatory Affairs, Performance Evaluation studies and Quality Assurance services from early-stage to well-established In Vitro Diagnostic (IVD) products.
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