The Importance of Document Control in MedTech Companies

What is Document Control? 

Document control in MedTech refers to the procedures implemented to manage the creation, review, approval, distribution, and maintenance of documents within an organization. Document control encompasses systematic control and organization of records and documentation to ensure compliance with regulatory requirements, quality standards, and best practices.  

Medical Device Document Control Requirements 

Document control must comply with Current Good Manufacturing Practices (cGMPs), and other regulatory requirements for standard operating procedures, organizational policies, and other essential quality processes. Several international guidelines govern the document control of medical device manufacturers, including: 

  • FDA 21 CFR Part 820.40: A set of regulations from the FDA that outlines the cGMP requirements that medical device manufactures in the US must follow within their quality system. This applies to all finished medical devices that are intended for human use in the US. This section specifically states the processes for document approvals and distribution, document changes, and the requirement of protocols and procedures for the control of all pertinent documents as highlighted in the FDA’s Quality Systems Regulations (QSR).  
  • ISO 13485: 2016: This guideline is set by the International Organization for Standardization (ISO) and is the global standard for medical device quality management systems (QMS). ISO 13485 calls for rigorous record-keeping and requires document control that extends document maintenance throughout the entire life cycle of the device. Furthermore, this guideline highlights a company’s requirements for their computer system validation.  
  • EU MDR: This is the Medical Device Regulation of the European Union (EU MDR). EU MDR focuses on the total product lifecycle, including periodic safety update reports (PSUR), documentation storage retention, and post- market surveillance.   
  • FDA 21 CFR Part 11: The Code of Federal Regulations Title 21 Part 211 (21 CFR Part 211) refers to the current Good Manufacturing Practices (cGMPs) set by the FDA for finished pharmaceuticals. FDA 21 Part 11 applies to your company if you are using any type of electronic document management software, and this guideline defines the acceptable criteria for electronic records and signatures.  

The Importance of Document Control on Quality Management Systems (QMS) 

Medical device document control is the backbone of an effective QMS. An effective document control system strengthens the management of files and allows for compliance with regulatory and quality systems within the FDA, ISO, and EU. This directly correlates to QMS as they are a vital component of compliance and quality culture in any regulated industry. When it comes to document control and QMS, you cannot have one without the other. Beyond a regulatory requirement, all industries and companies can benefit from a standardized solution for managing documents. The more seamless and documented an organization’s QMS system is, the safer and higher quality a product may be, ultimately improving patients’ lives.  

Document Control at Gilero 

At Gilero, having an organized system to manage the way that medical device documents are created and flow throughout our company is critical. How we keep track, review, and distribute our documents directly correlates with the effectiveness of our QMS. We strive to ensure that our products meet the highest standards of safety and quality. Our dedicated engineers are committed to ensuring that all Gilero projects meet internal and external quality specifications and regulatory requirements. During development, we are able to seamlessly transfer and create documents for our clients to use for their own regulatory submissions if needed. Our capabilities further include transitioning your device and documentation to operate within our ISO 13485 certified QMS to meet the same highest standards.   

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