ISO 13485
ISO 13485 is a quality management standard for medical equipment; this standard aimed at organizations with specialty in manufacturing medical equipment and services relevant to these products. In addition to requirements provided for in ISO 9001, this standard includes the medical equipment specific standards.
ISO 13485: 2003 is what is known as a “sector-specific” quality standard, similar to ISO/TC 16949: 2002 for the automotive industry or AS9100 for the aerospace industry.
What to Expect From Our ISO 13485 Consulting Firm?
We have been helping companies incorporate ISO standards for over 15 years. Our ISO 13485 consultants are among the best in the business. We have helped over 300 companies reach their goals; we also offer a guarantee that they’ll pass their audit the first time, or we will pay for re-certification. We understand that when you make medical devices, you have a liability to patients. That’s why it’s important to have the ISO 13485 certification to ensure a certain level of performance. Businesses are more apt to secure a contract with organizations that have proven documentation that they’ve mastered certain skills. If you secure our services, here’s what you may need to know about ISO 13485 certification.
Diagnoses, prevention, monitoring, treatment or alleviation of disease
Diagnoses, monitoring, treatment, alleviation of or compensation for an injury
The investigation, replacement, modification or support of the anatomy or of a physiological process
Supporting or sustaining life
Control of conception
Disinfection of medical devices
Providing information for medical purposes by means of in vitro examinations of specimens derived from the human body.
ISO 13485 Requires Knowledge of Rules and Regulations
In general, ISO 13485 teaches companies the best practices and approaches to design, manufacturing, development, and distribution. Companies with ISO certification must also remain in compliance with the regulations of the United States Food and Drug Administration. Every company with ISO 13485 certification should know the Current Good Manufacturing Practices (CGMP) and how to trace products and documentation related to the products.
Must Understand the Definition of “Medical Devices”
In general, ISO 13485 covers “any instrument, machine, appliance, or implant that may be used to diagnose, prevent, treat, monitor or alleviate a disease” to be a medical device. These devices can also be used to investigate, replace, modify or support the human body in some capacity. The devices may also be used to disinfect devices or control conception. Any company that meets these criteria will be eligible for the ISO 13485 certification.
Fast and Effective ISO 13485 Certification
Our ISO 13485 consultants provide fast and efficient service. We have helped most companies achieve certification within 90 days. Our ISO consulting firm works with employees to ensure that all people within the organization are prepared to help them reach their goals.
100 Percent Guarantee
Our company offers a “100 percent” guarantee. If you don’t pass your ISO 13485 certification the first time, we’ll pay for you to be re-certified. You’ll get more business once you are ISO 13485 certified. Thus, most people view the guarantee as an extra incentive to get involved today.
ISO 13485 Certification Benefits Medical Device Companies of All Types
Even medical software companies have benefited from obtaining their ISO 13485 certification. More organizations would like to conduct business that can verify their abilities. ISO 13485 certification provides the peace of mind that companies are searching for in advance. If you want to learn more about the benefits of ISO 13485 certification, contact our consultants for more information.
