Our FDA 510(k) Consultant can prepare and implement the entire quality system audit per ISO 13485 or advise you on a specific subsystem to meet the FDA’s QSR compliance (21 CFR 820: Quality System Regulation). Our quality system program for medical device manufacturers focus on the proper implementation and sustainability of the following seven major subsystems:
Our FDA 510(k) Consultants can put a new and objective eyes on your quality management system. Since your Quality System is a living document and may undergo changes purposely or sometimes inadvertently, there could be subtle or more obvious changes may occur without recognition and change your SOPs. From our compliance experience, a good many of the FDA’s 483s occur when the Standard Operating Procedures (SOPs) and the actual procedure that’s followed by your company doesn’t match. Our aim is to identify those non-conformances and assist your company in correcting those anomalies and bring your company in compliance with FDA regulations.
Our FDA Consultants are recognized industry leaders in assisting medical device companies out of FDA audit related crisis situations.
Are you or your company is presently concerned or involved in any of the following crisis situation?
It is important that you get the guidance from a FDA expert to prepare and respond to each of these situations carefully and thoughtfully. Failure to promptly act or properly address the underlying issues could possibly result in your business being shut down, criminal/civil actions being filed against you or your company, and/or huge financial losses. We have seen many companies proceed without guidance and have ended up wasting a lot of time and money by not involving expert assistance during these critical situations. Since time is critical, our FDA Consultant can provide you some initial assistance in understanding what is going on and how to proceed further.
Please contact us immediately if you need assistance with ISO 13485 for Quality System Audits, or to meet FDA QSR requirements. We may be able to assist you.
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