ISO 13485:2003 Consultants and ISO Quality System Implementation Support
ISO 13485 is quality system standard designed specifically for medical device companies. The standard is mandatory for most Class 2a, 2b and 3 medical devices and IVDs 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.
Emergo Group, with offices in the United States, Europe, Canada, Australia and China, has helped hundreds of medical device and IVD manufacturers implement quality systems that meet the ISO 13485:2003 standard. Our team of ISO 13485 quality system consultants and Certified Lead Auditors have implemented ISO 13485:2003 systems for companies manufacturing a wide range of Class 1, 2a, 2b and 3/4 medical devices. We will work closely with you to determine your business needs, custom tailor a system that meet your needs, and make sure your quality system gets implemented on schedule and on budget.
Our quality systems meet all European, Canadian and Australian regulations…and are FDA GMP compliant at no additional cost!
Although we customize our solutions to every client, all systems we implement can meet the following standards and regulations at no extra cost to you:
- ISO 13485:2003
- FDA Good Manufacturing Practice (GMP)
- Canadian Medical Devices Regulations
Our system has been proven to work efficiently and we have been through the process with so many medical device and IVD companies that we guarantee you will pass your registration audit if you follow our plan.
Why choose Emergo Group as your ISO 13485:2003 consultants?
- Our ISO 13485 quality systems are fully customized They are not ”off the shelf” solutions.
- Emergo quality systems meet all requirements with regard to Europe, United States, Australia and Canada.
- Our ISO 13485 consultants and project management team work closely to ensure that your quality system is implemented on time and on budget.
- We are always accessible to you and provide unlimited off-site support (in addition to contracted on-site support) during your project.
- On-site training for your key employees is included in the cost of an Emergo quality system.
- No surprises: All of our projects are based on a fixed price, not an open ended “time and materials” basis.
- We guarantee that you will pass your ISO 13485 registration audit if you follow our system!
- We treat every client as if they were our only client. Customer service is very important to us.
Contact us today for a no-obligation consultation on implementing an ISO 13485:2003 quality system in your facility.
