Glossary Term
Predetermined Change Control Plan (PCCP)
Definition
A predetermined change control plan is a proactive strategy established to manage and document changes to a product or process within a controlled environment. In the MedTech industry, it refers to a structured approach that outlines how modifications to medical devices, materials, or manufacturing processes will be managed to ensure compliance, safety, and quality throughout the product lifecycle. This plan identifies specific procedures, roles, and responsibilities for implementing changes and includes predefined criteria for when and how changes should be made. By implementing a predetermined change control plan, companies can mitigate risks associated with product or process modifications, ensuring that any changes do not negatively affect the safety or performance of medical devices.
Relevance to the MedTech Industry
Regulatory compliance and quality assurance are critical to the success of medical device development and commercialization. A predetermined change control plan is essential for ensuring that any changes to design, materials, manufacturing processes, or documentation are evaluated, documented, and approved before they are implemented. Regulatory agencies, including the FDA (21 CFR Part 820), EMA, and ISO 13485, require manufacturers to have robust change control processes to maintain device quality, patient safety, and device performance. This ensures that any change, no matter how minor, is carefully reviewed to ensure it aligns with the original regulatory submission, thus minimizing risks to the product’s market approval and its ongoing compliance.
Additional Information & Related Terms
Related Terms
Change Control: A systematic approach to managing changes in the design, manufacturing, or documentation of a product to ensure that changes do not negatively affect the quality or compliance of the device.
Design Control: A formal process to ensure that medical devices meet user needs and regulatory requirements through each phase of product development.
Regulatory Compliance: Adherence to the regulatory requirements set by authorities like the FDA, EMA, and ISO to ensure that products are safe and effective.
Risk Management: The process of identifying, evaluating, and mitigating risks associated with the development and use of medical devices.