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Medical device companies must establish a change control process to ensure internal consistency throughout their quality management system and documentation.

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.

Where Does the Change Control Process Apply?

The FDA quality system regulations makes reference to several types of changes that medical device companies should manage through a formalized change control process:

  • Part 820.30(i) Design changes. Manufacturers must establish and maintain procedures for the identification, documentation, validation, review and approval of design changes before they are implemented.
  • Part 820.40(b) Document changes. Changes to documents shall be reviewed and approved by a designated individual. Each manufacturer shall maintain records of changes to documents.
  • Part 820.70(b) Production and process changes. Manufacturers must establish and maintain procedures for changes to a specification, method, process or procedure. They should be verified, validated or approved when appropriate.
  • Part 820.70(i) Automated processes. Software changes shall be validated before approval and issuance.
  • Part 820.75(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform re-validation when required.
  • Part 820.100(a)(5) Each manufacturer should establish procedures for implementing CAPA, including procedures for implementing and recording changes in methods and procedures needed to correct and prevent quality problems.

What are the Steps in the 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:

  • Identification - The first step to implementing change is identifying the need for change. What needs to be changed? Is it a design change, a document change or a process change?
  • Description - Describe the change in detail
  • Identification of Affected Documents - What documents are affected by the change? Design changes will affect your technical documentation, device master record, and design dossier. Changes to a manufacturing process might affect your working instructions or SOPs for those processes.
  • Signature of Approval - The changes should be authorized by a designated person, usually the quality manager.
  • Approval Date - In compliance with the FDA QSR document control requirements, document changes should always be documented with the date of the approval indicated.
  • Effective Date - An approved change may or may not take effect immediately.

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:

  1. Determine which EU requirements apply to your device.
  2. Determine the classification of your device.
  3. Implement a quality management system that is compliant with ISO 13485.
  4. Prepare a CE marking technical file or design dossier.
  5. Establish a physical location in Europe, or appoint a European representative for your company.
  6. Have your QMS and technical file/design dossier audited by a Notified Body, unless exempt.
  7. Obtain CE marking and ISO 13485 certificates from the Notified Body.
  8. Prepare a Declaration of Conformity (DoC), stating that your device complies with the appropriate directives.

Greenlight Guru Automates the Change Control Process

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.

Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.

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