ISO 13485 Certification

ISO 13485 Certification

ISO 13485 Certification

ISO 13485 is specific to the medical industry, and it provides the standards for medical devices. These standards were first released by the International Organization of Standardization (ISO) in Geneva. The standards originated from ISO 9001 and have been evolving for years into something that companies can use. Our California ISO 13485 consultant has been advising companies on how to become ISO 13485 certified for numerous years and has great success in terms of helping organizations pass audits.

What to Expect From Our ISO 13485 Consulting Firm
Michael Madewell has been helping companies incorporate ISO standards for over 15 years. This ISO 13485 consultant is one of the best in the business. He’s helped over 300 companies reach their goals, and he offers a guarantee that they’ll pass their audit the first time, or he’ll pay for re-certification. He understands 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
  • 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 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 goal.

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.


Quality Certification Preparation for the Following Systems: