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We work to get and maintain your Medical Device FDA approval.
Our experts have worked over 30 years on :
- FDA 510k devices
- PMA devices
- IDEs
- Exempt Medical Devices
- In Vitro Diagnostics
- Drug Device Combination Products
It’s not just our long term experience and depth of knowledge that goes to work for you, but also our practical experience at achieving results across the entire therapeutic spectrum. This experience allows us to anticipate issues before they come up so that your project overcomes the regulatory hurdles that cause other projects to fail.
We’ve put together every document you can imagine in all these areas :
~ GMP/GCP Compliance
~ SOP Writing and Audits
~ Biocompatability
~ Pre-Ide Meetings
~ Validation
~ QSR Compliance Audits
~ FDA Consultant-Audit Inspections and Operations
~ ISO Support and Training
Everyone acknowledges that a medical device FDA approval is difficult to obtain, difficult to maintain and traumatic to lose. That is why selecting someone with long term success is vital to your business.
While we know that FDA likes to call it’s 510k reviews 'clearances', we know that clearance to get into the marketplace is an APPROVAL !
That’s what we want for you.
You need an FDA consultant who knows the importance of fast and effective action.
Call us now at 248 747 8008 or email to sgoldner@regaffairs.net and discover how we can help you.
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