Incoming inspection
Ensuring the quality and compliance of materials and components is crucial in the medical device industry. Our consultancy offers specialized Incoming Inspection Services to help you verify that all incoming materials meet your stringent quality standards and regulatory requirements. By guaranteeing the integrity of your materials from the start, we help you maintain the highest standards of safety and performance for your medical devices.
Our Incoming Inspection Services Include:
- Material Verification: We conduct thorough inspections and tests to verify the quality and specifications of incoming materials and components, ensuring they meet your predefined criteria and standards.
- Certificates of Analysis (COA) Review: We review and validate Certificates of Analysis provided by your suppliers to ensure the materials meet all required specifications and regulatory standards.
- Sampling and Testing: We implement robust sampling and testing procedures to assess the quality of incoming materials. Our tests cover a wide range of parameters, including physical, chemical, and mechanical properties.
- Documentation and Traceability: We ensure all inspection activities are thoroughly documented and maintain traceability of materials throughout the inspection process, providing a clear audit trail.
- Regulatory Compliance: Our services ensure your incoming inspection processes comply with industry standards and regulatory requirements, including ISO 13485, FDA, and EU MDR. We keep you updated on regulatory changes to maintain compliance.
Why us?
With extensive experience in the medical device industry and a deep understanding of regulatory requirements, our consultancy offers tailored solutions to enhance your incoming inspection processes. We help you ensure that only high-quality materials are used in your production, safeguarding the quality and safety of your medical devices.