Ridge Rim Associates, LLC: Manufacturing and Quality Systems Consulting

	Ridge Rim Associates, LLC
	Regulatory Documents and Clinical Publications Healthcare Manufacturing and Quality Systems Solutions

Manufacturing and Quality Systems

Documentation:

Full Quality Systems Regulations (QSR) Documentation
Validation Protocols and Reports
Manufacturing Documentation: Standard Operating Procedures, Test Methods, Purchasing Specifications
ISO 13485 Submissions

Compliance:

Design Control
Purchasing Control
Vendor Qualification
Audits
Risk Management

Manufacturing:

Strategic Planning
Vendor Selection
In-source / Out-source Decisions
Project Management

Facilities:

Owner's Representative
Design Consultations

Cory completes his assignments with an efficiency based on an in-depth understanding of QSR and a practical experience of 'what works and what doesn't.'
- MW, Sr. Vice President, Clinical & Regulatory Affairs & Quality Management

I have watched Cory create a manufacturing department, staff it, run it and the results were high-quality, reliable diagnostic tests. The tests were well within the normal cost range and the manufacturing department had good morale and low turn over.
- DC, Director of Operations

Cory and I have worked together closely over the past two decades. ... In all respects, Cory performed at the highest level. I know him to be experienced and knowledgeable, conscientious, objective and effective in all he undertakes. ... I recommend him without qualification.
- RC, Founder and CEO