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Emergency Regulatory & Compliance Assistance

Is the FDA coming to perform an audit next week?
Did the FDA just show up unannounced?
Did you just discover a systemic adverse event?
Are you implementing a Product Recall?
How do you handle a 483 or a Warning Letter?
Do you need help with your Health Hazard Evaluations (HHE)?
Do you know you have 15 days to answer a Warning Letter or a 483 if you want the FDA to consider your answer?

How a company responds to an FDA Warning letter or even a 483 notice can make the difference between a quick resolution and a long expensive remediation program. It is critical to respond to each situation carefully and thoughtfully.

Emergency Regulatory & Compliance AssistanceRecalls, audit actions, and MDR filings must be handled properly and proactively to ensure patient safety and minimize any potential damage to a company’s reputation. An inadequate response to a finding or a misunderstanding during an audit can lead to a warning letter or a freeze on all submissions at the FDA, eliminating the ability to release product to the market. Even a change to regulations or guidance documents can lead to unanticipated removals, corrections, or involuntary recalls. Call us early in the process so that we can provide the greatest value to your firm.

RELAX.

MEDIcept personnel have been in your shoes. We have been on the front line with investigators, spoken to the FDA to delay audits, written corrections, and have had 483 forms annotated.

We can conduct a mock FDA inspection prior to the FDA audit, providing you with a list of action items that can be addressed and corrected so you are better prepared for the FDA visit.

At MEDIcept, we have both the experience and expertise to help you weather an audit or product safety emergency. We can provide assistance with:

FDA audit
Audit response
Health hazard evaluations
Medical product recalls
CAPA plan development, implementation, and effectiveness review
MDR filings

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The Latest News

What You Need to Know About GDPR

What You Need to Know About GDPR

If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data Protection Regulation (GDPR) contains both existing and new data privacy requirements that, if not met, can result in significant fines of up to 20 million Euro or four percent of annual turnover. Maintaining compliance is required of...
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Are You a Start-Up? We Can Help.

Last year the US medical device industry achieved over $150 billion in sales, making it one of the most lucrative industries in the country. However, launching a medical device start-up in this highly regulated industry can be fraught with challenges. Medical product start-ups need to minimize regulatory and compliance risk to attract early-stage investors and save money. To complicate matters even more, recent changes in FDA regulations make it more important than ever to limit potential...
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Covering All Angles of Quality Assurance

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today. Of...