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Omnex Medical Devices Quality Management System Services
Omnex specializes in implementations where the FDA 21 CFR 820 regulatory requirements and the European Union Medical Device regulation are integrated into the ISO 13485 QMS. We have also implemented management systems that included Japanese and Canadian regulatory requirements.
Training and Competency Development
Omnex offers comprehensive training and competency development for industries including automotive, aerospace, medical devices, high-tech, and and other manufacturing sectors.
Enterprise Quality & Integrated Management Software Platforms
Omnex's unified Enterprise Quality Management System (EQMS) solution will help you implement and manage quality processes efficiently, using a revolutionary software platform.
Consulting, Implementation, &
Coaching
Omnex will conduct a Discovery Analysis during
an initial assessment
Management Systems
ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate
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Supply Chain Management
Supply Chain Management refers to practices that make a supply chain efficient.
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Product Development, APQP/Core Tools and Agile APQP
Omnex helps your New Product Development Process (APQP and Core Tools) by improving new product launch Quality and Timing.
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Lean Six Sigma Strategy and I-IoT
Lean and Six Sigma Programs improve "speed or lead time" while Six Sigma reduces "variation or reduces defectives".
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Problem Solving and Statistical Tools
Omnex provides and supports a variety of disciplined problem-solving methodologies including 8D,Root Cause Analysis, A3 and 5 Why, among others.
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ISO/IEC 27001:2022 Cybersecurity
Omnex is a member of many of the ISO Technical committees that write the ISO 9001, ISO 14001, and ISO 45001 standards.
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ISO 26000 Social Responsibility & Sustainability
ISO 26000 is a guidance document for Social Responsibility.
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Newsletter Featuring Cybersecurity - The Training Calendar Edition
Essential insights on Cybersecurity and the 2025 Training Calendar!
Medical Devices ISO 13485:2016
Omnex partnered with a leading contract manufacturer in the medical device industry to help them achieve ISO 13485:2016 certification...
Changes to Medical Device Legislation, Adopting ISO 13485 to 21 CFR 820
21 CFR 820 contains the FDA requirements for Quality Management Systems (QMS). These...
Key Changes in the New APQP 3rd Edition and Control Plan 1st Edition Manuals
The New APQP 3rd Edition and Control Plan 1st Edition are in their early rollout phase...
Leveraging Artificial Intelligence for Enhanced Product Quality: A Comprehensive Guide
In today's hyper-competitive business landscape....
TISAX and applications to EVAV (Electric and Autonomous Vehicles)
TISAX, which stands for Trusted Information Security Assessment Exchange, is a....
The ISO 9000, ISO 9001 and ISO 14001 standard...
FDA’s Proposed Changes to 21 CFR 820
21 CFR 820 contains the FDA’s requirements for Quality Management Systems. These requirements have been around a long time (since Jul 1978)...
Best Auditing Practices using Software
Enterprise today is juggling many standards. An audit tells an organization whether it is adhering to statutory and regulatory requirements...
Enterprise Digitalization of Audits & Best Audit Practices
Enterprise Wide Digitalization of audits proved to be crucial for any kind of Industry...
Supplier Quality Management Journey
Overview of our journey in implementing supplier management, the challenges seen at a start-up, understanding what is needed and support...
Our Medical Devices Clients
- Abbott Laboratories
- Catalent Pharma Solutions
- Centor Rx
- Draegar Medical Systems
- Entrotech
- FDA
- Formulated Solutions
- General Scientific
- Genzyme
- Glenwood Laboratories
- Hologic Surgical Products
- ICU Medical
- Johnson Matthey
- Karl Storz Endoscopy
- Micro Machine
- Novo Surgical
- Orthomerica Products
- Pari Respiratory
- Quantigen
- Reshape Life Sciences
- Scitech Medical
- Silicon Microstructures
- Skytron
- Stryker
- TDK Corporation
- Vapotherm
- Zeman Manufacturing
- Zimmer Biomet
How Can We Help You
For any service request or to seek consulting, Our Customer Service Team is ready to serve you, round the clock.