Your key to global market access

For medical manufacturers seeking new market-entry opportunities, conformity with regulatory requirements is most often a prerequisite. Those who want to compete effectively should also have in place a properly implemented and maintained Quality Management System (QMS). To satisfy these QMS needs, many manufacturers are discovering the benefits of working with Intertek. With our expertise, experience and know-how, we are your single source for certification to ISO 13485.

What is ISO 13485?
ISO 13485:2003 provides a harmonized set of quality management system requirements for medical device manufacturers. Based on a process approach to quality management, it focuses on what the manufacturer does to provide safe and effective medical devices.

Your ISO 13485 certificate can help you enter almost any market in the world. It is currently recognized in most major markets (including the EU, US, Canada, Japan, and Taiwan), and will very likely become widely adopted by other regulatory authorities around the world. You can get it all with one single audit!

While it is based on ISO 9001:2000, ISO 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to ISO 13485 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485 also does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements.

Why should my organization become certified to ISO 13485?
Your quality system's conformity with ISO 13485 can help you reap the benefits of:

• Expanded market access
  National regulatory authorities require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
  
  
• Reduced cost of sales
  Your certification establishes your company's credibility and commitment to quality from day one. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers' trust and confidence.
  
  
• Improved overall performance
  Based on a uniform and widely accepted system of process control, your certified QMS helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners and customers, and give your business a real advantage in the marketplace.
  

Intertek - Just what the doctor ordered
Intertek has extensive, worldwide experience in the medical industry - both in quality systems certification and in product safety testing and certification. When you select Intertek, our expertise will help you achieve your certification smoothly and efficiently. Our long history in quality systems certification offers know-how you simply can't get anywhere else, along with:

• Worldwide recognition
  Intertek is fully accredited to offer certification to the ISO 13485 standard. We are also qualified by Health Canada as a CMDCAS recognized registrar. (Please visit our Accreditations page for more details on the Intertek legal entities holding these accreditations and recognitions.)
  
  
• Dedicated account managers
  Understanding the need for continuity and clear communication, your account manager will be your single point of contact for all services from start to finish, and will provide status updates and market information whenever you need them.
  
  
• Personal and insightful service
  Our network of accomplished and experienced lead auditors offers professionals dedicated to serving your needs. With their extensive knowledge of the medical industry, our auditors quickly get up to speed on the specifics of your business, resulting in a more efficient audit.
  
  
• A single source for all your testing and certification needs
  In addition to certification, Intertek delivers the benefit of more than 100 years of product safety and performance testing and certification experience. Whether it's your product or your process, you can rely on Intertek for all your testing and certification needs.
  

The Intertek advantage
Our knowledge, expertise, experience and industry insight promote an efficient, certification process from start to finish. We'll use our know-how to help you achieve your certification smoothly and cost-effectively.