Glossary Term
Component Standardization
Definition
Component Standardization refers to the practice of using uniform, interchangeable parts and materials across different products or product lines. In the MedTech industry, it simplifies manufacturing, reduces costs, and ensures consistency in product quality and regulatory compliance.
Relevance to the MedTech Industry
Component Standardization enables MedTech companies to optimize production processes, streamline supply chains, and enhance device reliability. By reducing variability, it ensures that components meet consistent quality and performance standards, which is essential for regulatory approval and patient safety.
Additional Information & Related Terms
Bill of Materials (BOM) Lists standardized components used in a device.
Design Controls Ensures standardized components meet design specifications and regulatory requirements.
ISO 13485 Governs quality management systems, including the use of standardized components.
Cost Reduction Strategies Component standardization is a key method for minimizing production costs.