Medical Device Manufacturing

ISO 13485

Are you an FDA Medical Device Manufacturing firm that is looking to improve your Quality System by adding ISO 13485:2003 to your list of registrations/certifications?

Or are your customers requiring this additional registration/certification.

We can help.

There are few industries where the importance of product conformity is as crucial as that in the design, manufacture and testing of medical devices.

The certification of a quality management system, specific for Medical Devices will be to your advantage and in many cases is required for customers or organizations who export their products to the global market.

The standard is mandatory for medium and higher class medical devices in Europe and Canada. ISO 13485:2003 is a stand alone standard specific to medical device quality systems. It contains requirements relating to design controls, process control(including environmental),validation and verification,special processes, traceability, record retention and regulatory actions, which are critical for the medical device industry.

Who would want to be registered to ISO 13485?

• Organizations currently manufacturing private label medical devices, but are looking at eventually selling their product in the European Union.
• Organizations, such as consulting shops, which design, manufacture and assemble medical and In Vitro diagnostic medical devices and component manufacturers.
• Organizations that manufacture In Vitro Diagnostic Medical Devices that want to be prepared for any future regulatory requirements.

Our auditors have many years of hands on experience in the Medical Device industry.
You will be working with audit professionals.

Contact us at 978-386-2516 or just click here to request more information.