FDA 510(k) Consulting, FDA 510(k) Consultant

Quality System Audit for ISO 13485 and FDA QSR Requirement (21 CFR part 820)

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:

Management Controls
Design Control
Corrective and Preventive Action (CAPA)
Production and Process Controls
Document Controls
Purchasing and Material Controls
Facility and Equipment Controls
Medical Device Reporting- 21CFR Part 803

Quality System Audits

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.

FDA Audits, FDA 483and Crisis Intervention Services

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?

Recently received a notice of a forthcoming FDA audit
Received an FDA Warning Letter
Received a non-conforming observations from an FDA audit (483)
Thinking about implementing a Corrective Action or Product Recall
Undergoing a Clinical Trial Investigation
FDA 483 Response Consulting

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.