Background on ISO 14971:2007
The Medical Device Directive (MDD), and IEC 60601-1 3rd Edition have been revised and "now require you to demonstrate that you have a documented risk management system in place, no matter what the probability or the severity of the risk is, to show that your device is safe". So as part of your ISO 13485 program you will also need to comply with ISO 14971:2007. You can also be certified to it. This standard provides a framework that a medical device manufacturer can use to develop a risk management system. The standard requires the manufacturer to identify the hazards associated with their products, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of the standard apply at all stages of the product's life cycle -from concept through post-production - ultimately leading to reduced risk due to possible hazards with the product.
Certification to ISO 14971 helps ease the certification and compliance to ISO 13485:2003 and provides the medical device manufacturer with added assurance that their risk management system adequately addresses fully the key requirements of the standard.
Among the companies we helped in their certification and compliance projects:
ISO 14971:2007 Certification consulting:
ISO 14971 Risk Management Implementation Consulting:
If your company wishes to have CALISO drive the implementation to comply and be certified to ISO 14791:2007, we offer an implementation service that follows a 5-step methodology: Gap assessment, quality management system upgrade, training, internal audit, and certification audit. This can be integrated to an ISO 13485:2003 certification program, OR added to an existing ISO 13485:2003 certification. We will provide and generate all the required documentation to meet the requirements of the standard. Check-out our Success Stories and References.
We can secure for you Federal Funding to cover the majority if not the totality of the cost associated with this program.
We guarantee your certification provided you follow our recommendation in a timely manner. The Turnkey Consulting is satisfaction guaranteed. If you are not satisfied with our work, you will get a full refund upon return of all the documentation generated or provided. The refund covers the latest billing period for onsite consulting.
To start your implementation call us at 1-800-306-1366
or fax us a PO at (510) 217-6621. There are no travel or accommodation expenses if we have a consultant in your area, otherwise, they are billed at cost. Our e-mail: Tiout@caliso9000.com
Link to the ISO 13485 certification consulting information. ISO 13485 is the quality management standard for medical devices.
