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Few industries are as heavily regulated as medical device manufacturing. Developing and producing a medical product is an expensive and time-consuming process even when everything goes smoothly.

Things can quickly become even more expensive and challenging if your company and staff are not prepared to deal with complex FDA regulations and any inspections or audits associated with them. Regulatory compliance is the cornerstone of success for any medical device and its manufacturer. Any medical device manufacturer out of compliance is essentially out of business.

Like any complex undertaking – especially one that potentially threatens life and limb if not executed properly – medical device manufacturing is all about preparation and practice to avoid unexpected and expensive stumbling blocks put in your path by FDA regulations.  That’s why it’s so important to prepare for a possible regulatory inspection to ensure that your staff is familiar with the FDA’s Quality System Inspection Technique (QSIT) and can handle an inspection with relative ease and efficiency.

FDA regulatory compliance best practices include working with a regulatory compliance expert to conduct a mock inspection and audit designed to uncover any potential weak areas in your staff preparation, processes, and documentation before you begin marketing your product. It’s important to understand and evaluate your quality system’s overall status and how to anticipate the types of questions and requests you may receive from FDA inspectors.

Medical technology is growing increasingly complex and sophisticated. As a result, the number of domestic and international inspections are increasing and even your contract manufacturers are being assessed by the FDA. These inspections are not similar to ISO 13485 or supplier audits.

The FDA has recently added a number of new inspectors, many with industry experience, advanced degrees, and a keen knowledge of how business works and how compliant systems are supposed to work. These dedicated, thorough inspectors will inevitably find any gaps or weaknesses in your quality system and records and focus in on those. A mock FDA Inspection will help fill those gaps and train your staff to successfully manage the audit.

Properly designed and implemented pre-audit preparation will help your staff understand:

  • How to prepare for and manage an FDA audit
  • What FDA inspectors look for during an inspection
  • Inspection psychology – how to stay calm and focused during an FDA audit
  • How to successfully address typical compliance issues

To make the mock audit as thorough and effective as possible, it should include:

  • A professional, objective, and in-depth post-audit assessment that analyzes your company’s state of readiness
  • A post-audit action plan that details and prioritizes corrective actions necessary to reduce potential non-compliance weaknesses and vulnerability
  • Follow-up inspection awareness training based on the mock audit’s outcome

An experienced FDA regulatory compliance consultant should also be able to provide you and your staff with any additional support, information, and guidance prior to a real FDA regulatory compliance audit to help ensure positive results.

Unfortunately, FDA audits are a fact of life for medical device manufacturers. Mock FDA audits and gap assessments are your best defense against potentially damaging non-compliance issues that can affect your products and your company.

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