Emergency ServicesFDA Inspection? 483 or Major Observation? Warning Letter? Product Recall? Reportable Event?
Stay calm. Help is on the way.
If you manufacture a medical or in vitro diagnostic device, emergencies happen. The FDA can inspect you at any time with very little or no notice. An adverse event can occur. How prepared you are can differentiate between an efficient and cost-effective response and a prolonged, expensive struggle to resolve the problem. It is critical to respond carefully and thoughtfully.
- FDA inspection front room and backroom assistance
- Corrections and removal strategy and management
- Vigilance and MDR reporting strategy
- FDA 483 or Warning Letter response
- Major ISO or CE Mark Observation
- U.S. Customs detention
- BIMO audit support
FDA inspections can either be announced a few days prior or be unannounced. Internationally, your inspection may be announced with less than six months’ notice. Stressful? Our experienced staff has been in your shoes; we have been in front of FDA Investigators and ISO Auditors defending a Quality Management System. We have been in the back-room, predicting their next move, coaching subject matter experts before they go into the front room, and providing guidance to keep you compliant.
Corrections and Removals
If you have a potential domestic or international product recall, you have to know where to start and when to tell the appropriate authorities. All of these questions require a risk/benefit analysis. Every issue must be handled appropriately to ensure patient safety and minimize any potential damage to your firm’s reputation and bottom line. If you are not prepared, the process can become challenging and expensive.
Inspection or Audit Observation Response
You have just had an FDA inspection or an ISO/CE Mark audit and find yourself with a 483 or a Major Observation. Now is the time to call MEDIcept to help with your planning. Already submitted a response that they have not accepted? Still the time to contact us! You need an experienced team of consultants to provide expert advice, identify root cause, prepare a response, and plan for remediation to keep the company moving forward and the authorities happy.
I need help NOW!
Did you just receive a 483 notice or an FDA warning letter? Relax. We can help. Let our regulatory emergency response team show you how.
Need FDA or EU MDR/IVDR audit assistance?
Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.
Are you a start-up?
We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.