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Medical Device Document Control

The Good, The Bad, and The Essential

auditing iconYou may know the saying: “if you didn’t document it, it didn’t happen”. As cliché as that sounds, it is true. All successful businesses require a clear framework of defined policies and standardized processes. This is particularly true in the medical field. Good medical device document control allows evidence of your compliance.

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What is Document Control?

Medical device document control is the foundation for your business’ QMS. You wouldn’t build a house on quicksand, so why build a business on disordered, sub-standard processes?

Sometimes referred to as document management, medical device document control streamlines your organization’s activities. Being able to track and provide evidence of your actions makes meeting customer and regulatory requirements quick and painless.

Medical device document control is a system for tracking changes, revisions, and approvals to essential paperwork throughout the medical device life cycle. It takes you from development to commercialization and beyond, while checking for adherence to company policy.

Some examples of medical device paperwork you need to control are:

  • Quality manual
  • Quality policy and objectives
  • Technical documentation
  • CAPA reports
  • Design control documentation
  • Risk management
  • Complaints
  • Standard operating procedures (SOPs)

Documents are the Quality Manual, SOPs and Work Instructions, which are dynamic documents, whereas records are static once completed. Best practice is to always have a second person review a record and approve it prior to filing or archiving.

Whether manual or eQMS, QA Consulting can help. We can assist in your selection and implementation of an appropriate eQMS or set up a manual system and establish a purpose-built medical device document control system for you.

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What is The Purpose of Document Control?

Document management is essential for all parts of your business. From improvements to your QMS, to review and regulatory processes, all decisions must be written down. The success of your business (and by proxy, your innovations) relies on meeting key regulatory standards. Like a well-oiled machine, effective medical device document control improves company efficiency, allowing you to breeze through audits and inspections.

Medical device document control has multiple implicit and explicit benefits, some more obvious than others. Good documentation practice (GDP) is the gold standard in the medical device development world, which helps medical device designers, innovators, and manufacturers keep accurate documents and records. These documents provide evidence of your strict adherence to company procedure, diarise the series of events, and give decision makers quick-access to version control and accountability proofings.

Knowing the “five w’s and the h” (who, what, when, where, and how) of your business increases efficiency, improves device safety, and informs future processes. Proper documentation makes things easier to follow, but is often insufficient. Good medical device document and record control is also a necessary requirement for all major regulatory bodies. For medical device companies, failing to prepare the proper medical device document and record control really is preparing to fail.

Navigating the landscape of regulatory adherence may seem bewildering. But knowing how best to write, review and store your documentation doesn’t have to be complex or tedious. Our expert team provides key regulatory insights quickly and concisely.

Learn more about Document Do’s and Don’ts of medical device good documentation practices

Why Does it Matter to EU Markets?

Well-structured medical device document control systems yield benefits both now and in the future. Obtaining CE Marking and maintaining access to the European market is only possible if you satisfy EU MDR pre- and post-market regulatory processes. ISO 13485 remains the current standard by which manufacturers show compliance to the quality system requirements of the MDR.

Your ISO 13485 approvals checklist:

  • ‘Controlled’ QMS documents
  • Documents must cover the entire device lifetime
  • Review and approval processes must be cyclical
  • Transparent revision status of and changes to documents
  • Accessibility to previous document versions on request
  • Ensure that documents are legible
  • Proof of effective QMS implementation and requirements conformity
  • Appropriate SOPs for storage, security, retrieval, and disposition of records
  • Protection of any confidential health information
  • Recording version control and change management, including ownership
  • Preventing the deterioration or loss of documents
  • Evidence for all of the above

The QA Consulting team are experts in EU market access and MDR pre- and post-market regulatory processes. Learn from our years of experience and let our personalized approach bridge the gap in your current QMS document control.

Gain insight to our EU MDR Strategy

Why Does it Matter to the FDA?

Imagine the scene: you have just been alerted to a routine inspection from the FDA. If you fail this inspection, your device will not pass the next phase in development or perhaps delay regulatory clearance/ approval status. While your competitors spend the next few days frantically preparing for the audit, you are one step ahead. You can relax and feel safe with our water-tight medical device document control processes. With everything ready to submit, you are now free to focus on your business objectives, rather than worrying about a failed audit.

Your FDA readiness checklist:

  • Designate a responsible person(s) to review and approve documents
  • All approvals must be dated, signed and documented
  • Document and record reviews and re-reviews must be conducted in a consistent manner
  • Approved changes must be communicated transparently
  • Availability of current documents
  • Archive obsolete documents
  • Complete record of document changes
  • Change/revision history records must include accurate descriptions and specify the date of change effect
  • Document control that is FDA CFR 21 Part 11 compliant for e-signatories
  • Evidence for all of the above

With the QA Consulting team by your side, and access to our deep FDA regulations knowledge, you can benefit from tailor-made solutions for success in the States and worldwide.

Gain insight to our FDA Strategy

Stress Management with Document Control

Stay in control with QA Consulting.

The benefits of good medical device document control do not end after you’ve recorded the activities of your medical device development. Collaboration is an essential part of the med-dev process, that is easier with greater accessibility and clarity over version control and ownership.

Controlling your documents impacts the human elements of business. It boosts team morale, limits their stress, and allows skilled people to focus their time on other important tasks.

It also sends a clear message to competitors, customers, and key stakeholders. Your organization’s no-nonsense-attitude to compliance represents the quality, safety, and efficacy of your medical devices. If your competitors are cutting corners in their document control processes, where else are they cutting corners?

Taking your document control seriously creates the structure for efficiently locating documents and records to facilitate manufacturing, CAPAs, complaints and post- market activities. Medical device document control is the underpinning to your effective QMS, and your overall success.

How QA Can Help

A purpose-built medical device document control system shows stakeholders and buyers you are reliable professionals they can trust. Let our expert team analyze your company’s specific needs and develop quality systems that meet them.

We help you ensure consistency and accuracy in your document control processes leading to regulatory and quality success.

The end-users of your innovative medical devices will benefit from your partnership with a regulatory expert that understands how to bring your product to market safely AND document the process correctly along the way.

By accepting our team’s risk-mitigating regulatory strategy and educational approach to knowledge transfer, you acquire a safe, risk-free environment to learn from the industry’s best and brightest. We operate as an extension of your in-house team. That means when you win, we all win.

Let’s improve your document control today.

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