Regardless of where you choose to market your products, your medical device company must establish and maintain a quality management system (QMS) to ensure that they are safe and effective for the end user. Quality management systems undergo constant change throughout the life cycle of your product, and managing that change effectively is one of the most important functions of the QMS.
The purpose of a change control process is to manage changes in the QMS, preserving internal consistency within the system by ensuring that updates to important documents are reflected everywhere those documents are used. The change process should also include an element of approvals, ensuring that major changes to the QMS are reviewed by multiple stakeholders before implementation.
The FDA quality system regulations makes reference to several types of changes that medical device companies should manage through a formalized change control process:
When implementing a change control process, medical device companies need to ensure that they are meeting the change control guidelines as required by the FDA QSR. A formalized change control process ensures that your organization is performing process validations, conducting approvals and producing change records when required. Here's what to include on your change control documentation:
Medical device companies that effectively monitor the inter-dependencies of documents in their QMS will have an easier time identifying documents that are affected by a change and maintaining consistency within the quality documentation.
Obtaining a CE marking certification is a straightforward process, but you'll have to invest time and resources in preparing your company for a third-party audit by a notified body. Here are the basic steps for obtaining CE marking certification:
Greenlight Guru's eQMS software enables medical device companies to link or connect any documents or configuration items that are stored in the quality system. This simplifies the change management process, increasing the visibility of inter-dependencies between change records, documents, risks, design controls, customer complaints, audits, non-conformance reports and more.
When a specific document needs to be changed, Greenlight Guru makes it easy to quickly determine what other documents are affected and automates the approval and record-keeping aspects the change control process.