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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

FDA Updates Special 510(k) Guidance

FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process. In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements....

Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting

The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental amalgam. Recent post-market issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological...

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...