Navigating regulatory affairs and quality compliance (RAQA) with FDA regulations and international standards can be perplexing, leading to delayed projects and timeframes when 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 RAQA Services (Regulatory, Quality Assurance & Quality Control) offer a practical yet methodical approach to regulatory compliance and control processes to maintain quality from development through the patient experience.

REGULATORY SERVICES:

Regulatory Strategy
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 & Maintenance
Compliance SOP Development

QUALITY ENGINEERING SERVICES:

Design Control Process/Design and Implementation
Quality Systems Design & Implementation
Statistical Experimental Design
Risk Analysis
Process and Test Method Development
Software Development/ Systems Integration
Process/ Product Quality Issue Resolution (CAPA/ NCMR)
MDD to MDR Transition
Verification & Validation
Cost Reduction Strategies
Process Optimization/ Improvement
Technology Transfer
Process Automation
Production Equipment Relocation
Training & Education
Program & Project Management
Supplier Acquisition & Assessments
Document Control

INSPECTION READINESS SERVICES:

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

IS MEDTECH COMPLIANCE WORK HOLDING YOU BACK?

Meet Frank! He's overwhelmed with device compliance work - sound familiar? Don't worry Frank, there's a solution to your problems...

Remediation Case Study

PRODUCT EXPERIENCE:
Our client, a Class III medical device company, received multiple FDA 483’s as a result of Class-III product recall due to several system wide nonconformances, both major and minor, ranging from QMS, Operations, and R&D Sustaining.

Read the full details via the attached case study below.
large_team_remediation_case_study_square-1_engineering.pdf
File Size: 296 kb
File Type: pdf
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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

 SQUARE-1 CAPABILITIES INFORMATION

Square-1 Engineering offers support in a variety of medical device project disciplines across R&D, RAQA and Manufacturing Engineering.  Learn how we engage in each of those phases by clicking on the icon links below covering Square-1 Engineering case studies, medical device industry and project expertise.

CASE
​STUDIES

MEDICAL DEVICE
EXPERTISE

PROJECT
​EXPERTISE

Project Success Profile

1. Discovery
2. Project Planning
3. Deployment
4. Quality Assurance
5. Finish Line
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 success profile process:

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