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Concise Engineering, Inc.
- Website: http://www.concise-engineering.com/
- Standards: ISO 9001, ISO 13485, ISO 14971, ISO 10993
- Location: Clearwater, FL
- Email Address: jbushko@concise-engineering.com
Concise Engineering is a Medical Device Design firm that helps manufacturers design, iterate or accelerates a new product to market.
We specialize in Embedded Systems and can provide aid at any stage of the product design process.
Our team consists of high-end senior-level experts who can deliver results rapidly and efficiently across a broad array of expertise areas.
Our Passion:
- New Product Design & Development
- Start-Up Development Support
- RA/QA Strategy & Gap Assessment
- QMS & DHF Remediation
Our Services:
- Program and Product Management
- Systems Engineering (ME, EE, SWE)
- HFE & Usability
- Risk Management & Analysis
- Software & Electrical Compliance
- Verification & Validation Testing
- Quality Oversight
- Manufacturing Design Transfer
ISO Terms Explained
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.