Medical Device Consulting
What is ISO 13485:2003?
With our ISO 13485 2003 consulting services, your organization it will achieve registration quickly, cost effectively and efficiently.
Purpose of ISO 13485 2003
A successful implementation will demonstrate a company's ability to supply medical devices and related services to customers that comply with regulatory requirements.
ISO 13485 is not just product focused, but it focuses instead on the processes used to develop medical devices.
Keep in mind that you also need to comply with all relevant product and service oriented technical standards and regulations in this area of expertise.
We will document your Quality Manual, Procedures, set up all the required records and forms for you.
Complimentary FDA/ISO compliant software is included with our
ISO 13485 2003 consulting services.
No Requirement for Continuous Improvement?
Although ISO 13485 2003 is based on ISO 9001 2000 quality management standard and uses the same numbering system, ISO 13485 doesn't include the ISO 9001 requirements related to continual improvement and customer satisfaction.
ISO 13485 also focuses more on how procedures regulate and control activity and process performance.
Highlights of ISO 13485 2003
The standard highlights the following important factors in the processes surrounding medical device manufacture:
- FDA or other regulatory approval
- Cleanliness/sterility in the production area
- Labeling
- Traceability of non-conforming product
- Adequate testing of these important and sometimes life-saving devices
ISO 13485 is quality system standard designed specifically for medical device companies. The standard is mandatory for medium and higher class medical devices in Europe and Canada.
The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction and more...
ISO 13485 2003 Tune-Up
Old ISO 13485 systems can become bureaucratic and overbearing. Let our ISO 13485 2003 consulting services breathe new life into your Quality Management System, we can slash the costs and time you spend on Quality System maintenance.
Contact us for a free, no-obligation customized quote today!
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