Solutions

Quality Management Systems

We can work with you to develop a Quality Management System in compliance with the applicable standards and regulations and include: QSR CFR Part 820, with FDA QSR CFR Parts 7, 11, 806, 810, 820, Title 21 and ISO 13485.

Comprehensive quality management system with documentation for use from concept to commercialization
Strategic and tactical planning for quality management systems
Create and implement a quality management system in compliance with the applicable regulations and provide training for its use
Quality Management System transition from a manual database to an electronic platform
Upgrade of current quality management system based on new regulations
Remediation of current quality management system based on audit deficiencies

Design Control

We can engage with you to plan and develop customized solutions, maintaining the documentation for your design and development needs compliant to the applicable regulations including ISO 13485, 820.30, IEC 62304 and IEC 62366-1, and FDA QSR 21 CFR part 820.30.

Design and Development Planning
Software Life Cycle
Product Development
Test Method Verification and Validation
Product Realization Testing
Design Changes
Technical/Design/Phase Reviews

Risk Management

We can develop or upgrade your risk management needs and create streamlined solutions for each stage of your product life cycle needs.

Strategic planning for risk management in compliance to ISO 14971
Streamlined risk management and analysis from prototype to product launch
Comprehensive risk management documentation

Clinical Management

We can create solutions for your pre-clinical and clinical needs and also embed a clinical system into your current quality system.

Development of clinical system documentation in accordance with ISO 14155
Implementation of clinical requirements into existent quality management system
Clinical site qualification and product management
Clinical evaluation reporting

Quality Management System Audits & Remediation

We can create a customized audit readiness and/or remediation plan using effective techniques and prepare for your upcoming system audits.

Strategic and tactical planning for internal and external audits including notified bodies
Audit planning and readiness for internal/external/notified body audit
Simulated audits
Gap analysis of current quality management system to updated regulations
Corrective action/remediation plan for audit deficiencies from external regulator/notified bodies with agency response
Audit management for internal and/or external business needs

Training

We can provide training in various areas of the quality system and ensure compliance to the regulations.

Quality Management Systems
Risk Management
Design Control
Design Changes
Customer Complaint
Audit Management
Training Plans
Training Records
Post Market Surveillance

Document Control

We can customize your document control system and create a streamlined process for use.

Document Control Management
Engineering Change Orders
Change Management
Record Retention

Operations Management

We can help you plan, develop and maintain streamlined processes for your operational needs.

Purchasing
Receiving Inspection Set Up and Use
Calibration
Installation Qualifications
Tool and/or Equipment Management
Preventative Maintenance
Material and Inventory Management

Supply Chain

We can customize supply chain solutions to ensure that your suppliers provide optimal product quality.

Development and implementation of a supplier qualification system
Supplier Management
Supplier Performance Management
Supplier Corrective Action
Supplier Nonconformances
Supplier Changes and Product Equivalency Testing

Manufacturing

We can engage with your team to create optimal solutions for various manufacturing needs.

Manufacturing Process Instructions
Manufacturing Test Procedures
Manufacturing Documentation
Design and/or development of equipment, tools and fixtures
Operational and/or process qualifications

Quality Control

We can create customized quality control solutions to support your team .

Incoming Quality Control Set up and Use
In-process Inspection
Inspection Equipment, Tooling and Fixtures
Finished Inspection

Quality Assurance

We can develop methodologies which ensure that the product quality meets its requirements with strategic quality assurance planning.

Quality Planning
Quality Objective and Key Process Indicators
Quality Management Reviews
Product Approval and Release
Nonconforming material handling and management and/or remediation
CAPA handling and Management. and/or remediation
Post Market Surveillance Management and/or remediation

Clean Room Management

We can create solutions to your cleanroom needs and ensure compliance to ISO 14644.

Qualification & Validation Planning
Create qualification and validation protocols and reports
Qualification and Validation documentation
Clean Room Monitoring
Gowning Procedures

Regulatory Management

We can help you develop practical and effective solutions to your regulatory needs for both US and OUS locations.

Regulatory Plan
Compliance Management
Predicate Equivalence Analysis
Summary of Technical Documentation
MDSAP Gap Assessment
Declaration of Conformity
GSPR Assessment

Certification Readiness

We can help you achieve your certification needs to ensure business objectives are satisfied.

Navigation of the certification process and project planning for:
ISO 13485
MDSAP
CE Marking
Attestation of Conformity
State manufacturer license