How to Survive an FDA Audit for Medical Device Firms?

FDA Audit for Medical Device Firms
          FDA Audit for Medical Device Firms

FDA audit could be nerve-racking for medical device manufacturers if they are not well prepared. Over the last few years, medical device firms have encountered a significantly heightened number of inspections that resulted in increase in the number of citations. Although difficult, FDA audit is an important aspect of medical device industry. However, especially for startups, the first audit could be quite difficult to handle as the checklist of FDA could scare away the potential investors or customers, hindering the organization’s goal and efforts. Moreover, FDA sometimes announces their audit beforehand but the regulators may also turn up any time for inspection, without any notice. This implies, being a medical device manufacturer, you always need to be prepared for going through an FDA audit.

Here are some of the basic steps that you must follow to stay prepared and confidently survive an FDA auditfor medical device firms:

  1. Train Your Employees

As a medical device manufacturer you need to understand the regulatory standards and procedures, governing your business, thoroughly. Subsequently, you need to invest adequate time and money to train your employees on how to comply with the regulations. It’s also important to maintain comprehensive training records to show the auditors that your employees are well trained. Keep reviewing the regulations and stay updated about the changes. Organize training at regular intervals to ensure that your staff is up-to-date with the latest technologies and regulations.

2. Document Your SOPs

Your Standard Operating Procedures (SOPs) should always be well documented. Always maintain detailed documents for all the requirements regarding your procedures and activities. However, it’s also wise not to records too much specifics for your every activity as it may land you in trouble. Documenting too much of details makes it easy for the auditors to find issues in your procedures. Make it a practice to get regular feedbacks form your staff to make sure that your procedures are effective and up-to-date. Reviews help you in keeping your SOPs updated and in accordance to the refined procedures that you follow.

3. Perform Internal Audits

Internal audits are also an important way to ensure that your manufacturing unit is in full compliance with all the regulations. Your internal auditors could make recommendations and help in changing the procedures for betterment. Also, keep the senior management in loop for making improvements in procedures and ensuring that the remedial actions are taken in proper time and schedule. Hire third-party auditors for your internal audit team and conduct mock-audits. This not only helps you in streamlining your procedures but also gives your employees an idea about what to expect in an audit.

4. Manage Digital Data

Digital records regarding your procedures, bills, inventory and design history are helpful in demonstrating how committed you are towards accuracy, detailing and quality. Saving your SOPs in the form of electronic data helps you in implementing a smooth system and producing any document requested by the auditor immediately, without delay. However, make sure that you are using a reliable system for storing and maintaining electronic data that also helps in maintaining data integrity.

5. Organize Your Documents

FDA audit team puts a lot of emphasis on design control activities, especially if you are a new company. FDA would review you design history files to check how accurately you classify your product. The team also may want to check your 510(k) copies and you should have all these documents, up-to-date. While transitioning from design phase to production, there are always changes. FDA could ask you questions about these changes to evaluate how you assess the impact of such changes. FDA may also check your risk management files closely and you should be prepared to explain your risk based decisions.

Being always prepared is the key to survive an FDA audit for medical device firms confidently. Gain extensive knowledge about your work and the regulations governing the same, and ensure that your unit maintains compliance. In this way, even if the FDA audit team turns up in your firm unexpectedly, you would be confident to deal with it.



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