ISO 13485 Consulting

ISO 13485 certification has become the international indicator for consistent, competent services and production in medical devices industry worldwide for all size of businesses.

With the need ever increasing for better product and service at lower rate a good quality management system which promises the consistency in your medical devices is of utmost value. If you are like most executives, you spend your time improving revenues, cost, and productivity, not studying the ISO 13485 Standard, but still you’ve decided to become ISO 13485 Certified for one of these common reasons:

  • To satisfy a customer requirement
  • To gain competitive advantage
  • To improve your internal operations

Sync Resource provide “Turn-Key” Solutions to all your ISO 13485 compliance & certification needs. We align ISO 13485 standard to your business needs, without changing your existing business process. For State, Federal or Corporate Clients, our Principal ISO 13485 Consultant helps you with End-to-End ISO 13485 Implementation and Certification Process.

Our hands-on experience with product and service industry will make the ISO 13485 certification process an achievable target for you.

Value from our ISO 13485 consultation is not just creating a medical devices quality management system for your medical devices business but to understand how the medical devices quality management system applies to your organizational needs.

Note: Adherence to appropriate medical devices quality management principles will aid your organization in achieving business objectives and goals, whereas poorly designed medical devices quality management system would result in huge overall deterioration of your company’s structure.

We identify applicable processes, recommend improvements, introduce benchmark practices, provide on site training to various functional levels, Internal Audit service and External Audit support. Our process approach will improve operations without disrupting processes or delays and increase revenue with no extra expense.

We work with you to ensure that your ISO 13485 implementation is a genuine asset to your business by linking quality and efficiency to more targeted corporate objectives. We help you to set higher objectives and we have a plan to help you achieve them.