Compliance issues can be daunting.  GCI has successfully resolved many compliance challenges for our clients, both with the FDA and the EU.  GCI has extensive experience in the following compliance areas:

Audits (GMP/QSR, MDD/ISO 13485), 510(k) applications, technical files, design dossiers, gap analysis, preventive maintenance, manufacturing procedures, quality procedures, sampling plans, quality plans, corrective and preventive action, design history files, tool specifications and equipment drafting are among our many services.

» Audits (GMP/QSR, MDD/ISO 13485)

» 510(k) Applications

» Technical Files

» Design Dossiers

» Gap Analysis

» Preventive Maintenance

» Manufacturing Procedures

» Quality Procedures

» Sampling Plans

» Quality Plans

» Corrective and Preventive Action

» Design History Files

» Tool Specifications

» Equipment Drafting

We’re so confident in the quality of our work that we’ll even represent your organization during an FDA or MDD Notified Body audit. Our vision is the achievement of your CE mark or FDA audit with zero observations.

Please contact one of our Compliance Services representatives at Compliance@GCIBiotech.com.