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:
- Sales
- Marketing
- Customer service
- Manufacturing
- Distribution
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:
- Medical Device Training - Standards include: EU Directives, ISO 13485 Medical Devices, ISO 14971 and FDA Requirements.
- Developed Intranet-based ISO 9001:2000 TickIT business management systems.
- Medical Patient Sample Testing - Designed systems meeting the IVD EEC directive and the ISO 13485 Medical Devices standard.
- Developed and implemented ISO 9000 business management systems.
- Developed and implemented ISO 14000 environmental management systems.
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:
- Smiths Medical
- MedLogic
- Haemonetics
- Molecular Products
- Tisuemed
- Lantor
- Cochlear
- Ultravision
- Lifelab
- Jabil
- Johnson and Johnson
- NHC Technology
- SmartBead Technology.
- Novamedix
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:
- Where do you want your business to be in three to five years?
- What are the core processes that will get you there?
- Month-by-month, do you really know if those core processes are achieving what you need them to?
With these questions answered, he creates the processes needed to meet the unique goals of the business.
