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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

Mobile Medical Apps

In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs) which raise some unique concerns for compliance and challenges for regulation by the FDA and medical regulatory submissions. It is important to determine if your product is a regulated MMA or not a medical device. On May 17, 2019, the...
MEDIcept

Digital Health Innovation and Regulatory Compliance

Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based integration of medical devices, which promises to improve the delivery of healthcare, often at reduced costs. Telemedicine, wearable devices, artificial intelligence (AI), and remote diagnostic and monitoring systems are just some...

Two Premier Medical Device Firms Merge to Provide More Comprehensive Services

Ashland, MA: MEDIcept Inc, a leading international quality and regulatory consulting firm focused on medical device and in-vitro diagnostics (IVD), and Reilly & Associates, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies.The merger promotes the shared strategic goal of becoming a world-wide, leading quality and regulatory value-added service firm focusing on medical devices and medical technology....