Openwater QA-RA Systems is a medical devices consultancy owned and operated by Liz Streeter from her base in West Sussex. Since being established in 2008, we have gone through a number of changes, resulting in a top level Quality Assurance and Regulatory Affairs specialist company dedicated to the medical devices industry.
Liz’s skills and experience encompass the following main QA/RA areas:
- ISO 13485:2016
- MDD 93/42/EEC
- UK MDR 2002 – UK CA Marking
- MDR 2017/745
- IVDR 2017/746
- LSAS
- Quality Management Systems for any form of Economic Operator
Why Choose Openwater QA-RA Systems
- Proven track record of installing successful ISO 13485 systems
- Full training offered on ISO 13485 and MDR 2017/745
- Technical documentation for CE and CA marking
- Product/purchase specification writing to ensure great subcontractor partnerships
- Seamless integration of QMS processes into existing business systems
- Systems installation for any type of Economic Operator – manufacturer, responsible manufacturer, virtual manufacturer, distributor
- Systems for Labour Standards Assurance that will be compliant with NHS Supply Chain requirements and will pass Notified Body scrutiny
Services
Openwater QA-RA Systems can write Quality Management processes to ISO 13485 that will meet not only the standard requirements but those of the company concerned as well. These systems are written around the organisation’s existing processes and practices, as far as is possible, and will embed seamlessly into the workings of the company. Liz’s personalized training and support ensures the systems become second nature to all staff and top management alike.
The advent of the Medical Devices Regulation presents a new challenge with many changes which Liz is well placed to assist with. She integrates this regulation into quality management systems and advises and assists with the updating of the Technical documentation.
With a background in manufacturing, Liz provides extensive specialist knowledge and advice based on her experience with quality control requirements, testing and special process operations, such as cleanroom manufacture. She also strives to be always up to date with all current legislation.
All specialisms can be provided on a project basis and end only once the systems are fully up and running. Where clients are small businesses, or businesses of any size who would like some extra assistance, Liz continues to offer support on a mutually agreed time basis.
About
Liz has over 30 years of experience in Quality Management. After starting out working with the NHS, she moved on to work in manufacturing, always in quality assurance - usually getting involved with all aspects, from manufacturing, quality control and laboratory testing through to supporting systems of any QMS. She worked for 12 years for a medical device company, gaining knowledge about medical device raw materials, manufacture and testing, and at this company she installed and ran the cleanroom that operated for 2 years in the early 2000s.
Since starting her own specialist consultancy business in 2008, Liz has worked for clients who manufacture a variety of different types of medical devices, developing expertise across a wide range of products and materials. She has devised Quality Management Systems for actual manufacturers, responsible manufacturers and distributors. Liz is also a member of the Chartered Institute of Quality.
She is used to working at all levels, running high level meetings, working on the shop floor and helping to find solutions to problems wherever they arise. Her skills and knowledge have been continually developed, sharpened and honed, and grow with each regulation change and challenge.
Liz is supported by a brilliant administrator who runs the back office details like clockwork, ensuring everything is done in a timely manner.
Partner Links
Some of the companies we have worked with, and continue to work with, can be visited below:
NES Health Ltd (XPO HEALTH LIMITED)
Cutting Edge Surgical Instruments Ltd
The Chartered Quality Institute
Specialised Experience:
- Products: Ostomy Care products, Urology products, Surgical Instruments, Analytical and Clinical Sample Containers
- Materials: Plastics and Hydrocolloid
- Workable processes
- Technical documentation
- Cleanrooms
- Labour Standards Assurance