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For manufacturers of medical devices who want to provide safe / effective equipment, a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements. Since 2003 when ISO 13485 was first implemented and recognized by the Global Harmonization Task Force (GHTF), it has quickly become the model standard for the medical industry. Also, for medical manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who want to compete effectively also should have a properly implemented and maintained Quality Management System (QMS). To satisfy these conformity and QMS needs, many manufacturers are discovering the benefits of working with a third-party testing company.

The benefits of Management Systems Certification:

The management system's conformity with ISO 13485 can help your company open doors to untapped domestic and international business opportunities, and 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 management 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 − The certification establishes your company's credibility and commitment to quality. 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 Performance − Based on a uniform and widely-accepted system of process control, your company's certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.

The Benefits of an ISO 13485 Certification from the Client's Perspective:

The CDG ISO 13485 certified companies cover a wide range of businesses. For Example, CDG has certified raw material suppliers, manufacturers of electrical components, manufacturers of tumor marker antigens and antibodies, packagers of dental implants and manufacturers of partially finished hips and knees. The following three customers share their reasoning for obtaining ISO 13485 registrations and explain the benefits that they've experienced.

Our client's management says Business Growth was directly related to positive impressions that our customers recognized by us obtaining certification to ISO 13485. They go on to say the specific benefits are:

1. Quality Management System which maintains compliance to the requirements of the medical device industry and is in line with the FDA QSR standards.

2.Improved manufacturing controls and procedures that ensure safe and effective medical devices.

3.Greater assurance that product will continue to meet customer specifications.

4. Improved Risk Management and Design Controls to assist customers in the development and improvement of their products.

5. Improved efficiency in assisting customers obtain market clearance and approval to meet aggressive sales and marketing goals.

By becoming Certified in the ISO 13485 Standard your company will:

1. Increase the probability of making safe and effective medical devices

2. Meet regulatory requirements

3. Meet customer expectations

4. Help monitor the effectiveness of your supply chain

This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard. With ISO 13485 certification you will be able to enter any major market around the world with one audit! By becoming ISO 13485 certified your company's Quality Management System (QMS) will be in line with the Food and Drug Administration's (FDA) QSR standards.

Additional Benefits of ISO 13485 Certification:

1. Increased Efficiency

2. Cost Savings

3. More Effective Risk Management and Quality Assurance

4. Improved ability to respond to Customer Requirements

Choose CDG today for your ISO 13485 Certification! Our knowledgeable and accredited Registrars will help make your certification process smooth from start to finish. By choosing a reputable company such as CDG your customers will realize the commitment your business is making to produce the highest quality, safe, and effective medical devices on the market.

Facts About ISO 13485:

1. ISO 13485:2003 was written as a model to meet the quality system requirements of various global regulations.

2. ISO 13485:2003 is compatible with other "non-quality" management systems, such as ISO 14001, or OHSAS 18001.

3. If a company meets ISO 13485:2003 requirements, it should easily be able to meet the FDA QSR requirements. Although ISO 13485:2003 has not been adopted by the FDA, the FDA participated in writing ISO 13485:2003 to ensure the requirements are aligned.

Risk management is a key element of ISO 13485:2003.

TR 14969 is a guidance document for the use and implementation of ISO 13485:2003.

ISO 13485:2003 was written as a tool for maintaining processes, not for a business improvement model.

Unlike ISO 9001:2008, ISO 13485:2003 will not allow manufacturers to rationalize documentation. In order to ensure companies meet regulatory requirements, ISO 13485:2003 is more prescriptive, and requires that certain procedures still need to be documented.

There is no significant relationship between ISO 13485:2003 and ISO 9004:2008.

Medical Devices for ISO 13485:

1. Instruments

2. Appliances

3. Implants

4. Machines

5. Software

6. Materials

7. Calibrators

8. Apparatuses

9. In Vitro Reagents

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