Services we offer
Experienced. Efficient. Timely
Quality Audits

Quality Audits

Audit Specialists at Your Service

Medical Device Recall

Medical Device Recall

Recalls Happen; We Can Help

In Vitro Diagnostic Devices – IVD

In Vitro Diagnostic Devices – IVD

Our Regulatory Experts Are Second to None

FDA 483 & Warning Letters

FDA 483 & Warning Letters

Need Help Responding to an FDA 483?

FDA & ISO Quality Systems

FDA & ISO Quality Systems

Proven Systems for Seamless Business Management

EU CE Mark Certification or FDA 510(k) Submissions

EU CE Mark Certification or FDA 510(k) Submissions

Our Certification and Submission Experts Are Waiting To:

Still have questions?

We don’t just consult; we roll up our sleeves and solve problems.