ISO 13485 Consulting Certification for the Medical Device Industry - Why it is Crucial?

1. ISO 13485 Consulting Certification for the Medical Device Industry: Why it is Crucial? Barile Consulting www.barileiso9001consulting.com

2. ISO 13485 Consulting ISO 13485 Certification is an internationally recognized standard for quality management for the medical device industry designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world. ISO 13485 consultants’ certification contains requirements those are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

3. How ISO 13485 Consultants’ Certification Benefits Your Organization? • If you manufacture or market a class-II or higher risk classification device and sell it outside the United States, you probably need to be ISO 13485 certified. ISO 13485 Consultants’ certification can also expand your market access and improve the profitability of your organization. • ISO 13485 Consults to help you in • Implementation of a quality management system with several enhancements • Risk management approach to product development and product realization • Validation process • Compliance with statutory and regulatory requirements • Effective product traceability and recall systems

4. Long Term Benefits of ISO 13485 Consultants’ Certification • It is the de facto standard for global medical device QMS compliance for medical devices, and is a prerequisite for access to most major markets worldwide. • ISO 13485 Consultants’ certification requires commitment and effort to attain, so it gives you additional credibility with potential customers. • A refined quality management system will increase efficiency, enhance product quality, and improve customer service within your company.

5. What We Offer in the Field of ISO 13485 Standard & Certification As one of the largest ISO management system certification consulting companies across the world with clients across numerous countries, our knowledge and experience of the standards is unsurpassed. We understand how to fully exploit the benefits of your quality management system to ensure you unlock the true potential in your organization. We provide you unmatched ISO 13485 consulting service to ensure your quality management system certification adds value to your organization.

6. Contact us Get in touch with us now to get your organization ISO 13485 certified in the most effective and efficient manner while realizing the true benefits of the certification by seeking help from our highly experienced ISO 13485 consulting officials. Address for Communication Barile Consulting Services, LLC PO Box 33028, Cleveland, OH 44133 Office: (440) 628-8271 Email: dabarile@barileconsulting.com Website: www.barileiso9001consulting.com