ISO 13485 Medical Devices Quality Management Systems

The ISO 13485 Medical Devices standard is designed specifically for medical device companies. It has specific requirements for accountability, design controls, records retention, process control, customer feedback and more.
As a business consultant, David Owen brings a wide range of experience to every project. Past work includes training for ISO 13485 Medical Devices requirements, and developing ISO 9000 business management systems.

His goal is always to raise standards, improve efficiency and increase profits. He focuses on implementing or improving core business processes, including:

Expertise in International Standards - ISO 13485 Medical Devices, ISO 9000, ISO 14000 and More

David draws from his experience as an engineer, QA expert and management consultant. In his thirty years as a business consultant, he has worked in many industry sectors in Europe and North America. He has experience designing processes and systems to meet international regulatory standards. Past projects include:

ISO 13485 Medical Devices Standard - Clients

David has helped many clients implement the ISO 13485 Medical Devices standard and achieve the CE mark.
In his projects involving ISO 13485 Medical Devices standards, David has worked with:

In his work with SmartBead, a UK developer of new medical diagnostic products, he developed an ISO 13485 business management system to meet the Medical Devices requirement for CE marking.

ISO 9000 - Clients

He designed ISO 9001:2000 TickIT systems for Manpower Software and Smart421.

Projects meeting ISO 9000 standards were completed for: Abatron, Abbey Security, Nikaroand and UUNET (now part of MCI).

ISO 14000 - Clients

He designed ISO 14001:2000 systems for Cardmasters and Image Office Cleaning.

The Approach - Results-Driven and Client-Focused

To achieve the results his clients want, David starts each project with three key questions:

With these questions answered, he creates the processes needed to meet the unique goals of the business.