Compliance with FDA regulations and international standards can be perplexing, leading to delayed projects and timeframes if done incorrectly. Non-compliance may bring about even bigger problems. As a result, regulatory agencies demand manufacturers maintain compliance throughout all stages of a product’s lifecycle, from concept through post-market compliance. Square-1’s team of seasoned experts understands these challenges while knowing how to keep your team on track while minimizing downtime.

REGULATORY SERVICES:

Regulatory Strategy
Lifecycle Management
Product Gap Analysis & Remediation
FDA/Agency Meeting Preparation
Face-to-Face Representation at Agency Meetings
IDE, 510(K), PMA Preparation & Submissions
Device Labeling
Complaint Handling System Implementation
Complaint Handling System Review & Maintenance
Compliance SOP Development
Project Management & Training
Process Improvement & Implementation

INSPECTION READINESS SERVICES

Simulated Inspections
ISO, MDD, MDR, MDSAP
Risk-based Preparation
Inspection Oversight and Management
Experiential Learning for SMEs
483/ Warning Letter Responses
Training & Education

PRODUCT EXPERIENCE:

Class I, II (a & b), III
Delivery Devices
Diagnostics
Disposables
Endovascular
Neurovascular (stents, coils, catheters)
Ophthalmics (IOLs & ICLs)
Plastic Injection Molded Components
Sensing & Monitoring Systems
Surgical Instrumentation
Vision Systems
Wellness Devices

How We Ensure Successful Project Execution

Our clients enjoy working with us because of our proven ability to deliver results beyond their expectation using a systematic, yet flexible approach to project engagement, delivery and successful closure.

Learn more about our project engagement process:

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