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ISO 13485:2016

Medical Devices

This ISO standard specifies requirments for a Quality Management System that can be used bu an company invloved in one or more stages of the life cycle of a medical devices, including design, development, production, storage and distribution, installation servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities.

Medical Device Management 

There are many complexities to this management standard and extensive consideration's, tasks and objectives including:

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This Medical device standard management system should be operating and functioning real time, and be easily accessible to staff at all times. 

The need to comply with the international standard ISO13485 requirements, Medical Device Regulations (MDR) and FDA is challenging for managers in all medical device related industries and healthcare sectors.

BPAMedical365 is an innovative software for medical quality & compliance management, ready to use in your trusted Office 365 environment, including the main modules of our quality & risk management software plus additional modules for eSignature and product lifecycle management.

To accommodate this we can offer BPA Quality 365 an innovative software for Medical Compliance Management software platform, provided by BPA Solutions.

Consider undertaking an in-depth risk analysis of your business and develop your own definitive Medical Device Management Blueprint and become the clever complaint company you are!

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