Medical device ISO class 7 clean room services

Class 7 Cleanroom

Medical device ISO class 7 clean room services

ISO Class 7 Clean Room

The Vascular Flow ISO Class 7 rooms provide air cleanliness of a maximum of 352,000 particles per cubic meter at 0.5μm and 60 to 90 air changes per hour. Vascular Flow use this cleanroom environment for medical device manufacturing and packaging processes.  Each client has dedicated cleanroom space and time.

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Craig Dunlop, General Manager, Vascular Flow Technologies

General Manager

Craig Dunlop

Craig joined Vascular Flow in May 2014.  He comes with over 20 years of industry experience as a medical device engineer and manager.  Most recent positions held were at Vascutek Ltd as OEM Technical Manager and Development and Operations Manager for ePTFE Products.
Craig has a broad portfolio of successful new product developments and introductions within the Cardiovascular arena and has worked in both Europe and USA.
Craig was educated in Engineering and Operations Management at University of West of Scotland.

Kate Full at Vascular Flow Technologies

Financial Controller

Kate Full

Kate joined Vascular Flow Technologies from Braveheart Ventures where she was responsible for the evaluation and development of investment opportunities, focusing on financial diligence.
A Chartered Certified Accountant, she trained with PriceWaterhouseCoopers, qualifying in 2001 and continued in professional practice until joining Braveheart in 2004. Prior to embarking on her professional training Kate held a number of different accounting roles in a variety of industries including manufacturing, wholesale and leisure.

Angela Paterson, Head of QA & Regulatory Affairs, Vascular Flow Technologies

Head of Quality Assurance & Regulatory affairs

Angela Paterson

Angela joined Vascular Flow Technologies in April 2013 after spending the previous 14 years in Quality Assurance within a vascular graft manufacturing environment. Prior to this she spent three years in laboratories/ Biotech. Angela also has extensive experience working with regulatory agencies e.g. US FDA and Japanese PMDA.
Angela has a BSc in Applied Biosciences from Glasgow Caledonian University.

Jim Veitch, Head of Global Business Development, Vascular Flow Technologies

Head of Global Business Development

Jim Veitch

Jim has over 2 decades of experience in the Global Medical Device Business with a special interest in cardiovascular, LVAD, TAH and dialysis disease areas.
He works with numerous large and small device companies assisting in the successful promotion and commercialisation of their novel technologies.
This experience will help guide Vascular Flow through the next stages of their development and global expansion.

Graeme Houston, Non-Executive Director, Vascular Flow Technologies

Non-executive Medical Director

Graeme Houston

As Chair of Clinical Imaging and Intervention, University of Dundee, Professor Houston is a Consultant Cardiovascular Radiologist with an interest in endo-vascular therapies, and non-invasive vascular imaging using MRI and Ultrasound.
His medical training at St. Thomas’s Hospital in London followed first class honours science degrees in physics and pathology at Cambridge University.
His endo-vascular training was undertaken initially in Glasgow and further developed as a Fellow at the University of British Columbia, Vancouver, Canada. He is responsible for intellectual property, and as Medical Director is responsible for the clinical scientific research in the Spiral Laminar Flow™ field and stent technology.

Medical Device Development

Become an Investor

We are always interested to hear from potential investors with a view to accelerating our ambitious business plan and global reach or hearing from potential partners with a view to developing our Spiral Flow Technology in other areas.
If you want to find out more about investment opportunities in Vascular Flow Technologies, you can contact us directly on +44 1382 598 532.

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Medical device ISO class 7 clean room services

ISO Class 7 Clean Room

The Vascular Flow ISO Class 7 rooms provide air cleanliness of a maximum of 352,000 particles per cubic meter at 0.5μm and 60 to 90 air changes per hour. Vascular Flow use this cleanroom environment for medical device manufacturing and packaging processes.  Each client has dedicated cleanroom space and time.

Medical device Contract assembly services

Contract Assembly Services

Vascular Flow provide medical device contract assembly services to successfully deliver to our clients specifications. We assemble a wide range of medical devices for the world’s leading companies at low and medium volume manufacturing scales in our ISO Class 7 cleanroom environment.
Contact us today to find out how we can help you with your medical device contract assembly needs.

Medical device contract packaging services

Contract Packaging Services

Vascular Flow offer innovative packaging solutions for your medical device. Our ISO Class 7 cleanroom processes ensure 100% product or customer specific isolation to avoid contamination
We are specialists in low volume medical device contract packing projects for small and medium sized organisations. Our packaging solutions are optimised for process reliability to ensure consistent on time and on budget.
Contact us today to find out how we can help you with your medical device contract packaging needs.

injection moulding services

Injection Moulding Services

Our recognised know-how in plastic injection moulding enables Vascular Flow to offer our clients comprehensive and customised support, from the design of their devices right through to production, all in accordance with international regulatory requirements (ISO 13485-2016, ISO 15378 and QSR – 21 CFR part 820).

Medical device label printing services

Medical Device Label Printing Services

Vascular Flow Technologies are here to help get your products noticed. Our team is motivated to see your product succeed, whether you need a hundred labels or thousands of labels applied every day, we can meet your demand. Vascular Flow work with you to ensure only adhesives and topcoats that are compatible with your sterilization process are used.

Computer Aided design Services

Computer Aided Design Services

Vascular Flow utilises the latest Solidworks 3D CAD software to compliment its R&D offering.
Our highly skilled technical team utilises CAD to create and improve designs and reduce costs and is key to good communication of new products and documenting design history. We also have experience in parametric design processes and non-linear/complex curvature model creation.

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Finite Element Analysis

The team of experts at Vascular Flow can predict the structural performance of medical devices in conjunction with biological tissues using Finite Element Analysis (FEA).
Out team can couple together different physical effects using FEA, including heat and mass transfer, chemistry, fluid flow, electricity and solid mechanics.
We direct FEA to accelerate pace of innovation, decrease clinical trial costs, mitigate design risks and streamline the approval process.
Computational models are used to obtain information that are either too challenging or impossible to be obtained experimentally in pre-clinical or clinical studies.
To find out how Vascular Flow can assist you in your new development project, get in touch today.

In Vitro Flow Services (Bench Models)

In Vitro Flow Services (Bench Models)

In vitro tests with a bespoke, computer-controlled flow rig are used to verify the outcomes of medical devices in a controlled environment.
Vascular Flow has the capability of producing complex geometries and pulsatile flow to represent medical devices in blood vessels. We measure flow rates with pressure and flow sensors, and complex flow structures are measured with Doppler ultrasound. Blood viscosity and density are reproduced with blood mimic fluid.
In vitro flow & deployment (Cadaveric models)
Cadaveric models are the most realistic anatomical models to test vascular devices prior to pre-clinical trials.
Vascular Flow work in partnership with the University of Dundee and Tayside Health Board to test the deployment and flow outcome of vascular devices in a cadaveric anatomical model. The cadaveric bodies using the Thiel soft-fix method, which preserves them with life-like flexibility and tissue quality. Flow and anatomy are visualised with ultrasound, fluoroscopy, CT or MRI.

Project- Management and Delivery Services

Project Management & Delivery Services

Vascular Flow Technologies highly experienced team has a proven track record of taking products from initial design concept to market.
All projects delivered by Vascular Flow are ISO13485 compliant with Design History File generation.
We can work in collaborative partnerships or provide full turn-key solutions, offering flexible design, development & verification costing models.

Prototyping & Testing Services

Prototyping & Testing Services

To assist our clients to rapidly get their products to market, we offer a range of rapid prototyping services including injection moulding and plasma treatment.
We have vacuum chambers, furnaces with gas retort and laminar flow and extraction cabinets to allow us to safely and effectively work with your device design.
The product testing services we offer our clients are numerous and include:
· Burst testing
· Tensile testing
· Compression testing
· Suture retention testing
· Repeat puncture testing
· Permeability testing
· Package peel testing
· Dimensional testing
· Kink testing
· Flow testing
· Ultrasound doppler analysis
Our research team are highly adaptable and will work with you hand in hand to get the job done and move your project forward at pace.

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Regulatory Support

Vascular Flow Technologies has extensive Class IIa, IIb, III device submission experience with both CE and 510k submissions and approvals.
We can support full ISO 13485 design history and technical file generation & ISO14971 Risk Assessment.
Our experienced team can undertake full Clinical Literature Reviews on your behalf to support the early-stage feasibility processes.

Medical Device Development Services ISO Standard Performance Testing Services

ISO Standard Performance Testing Services

Vascular Flow has invested heavily in equipment and enhanced its laboratory to capitalise on the in house experience gained through previous projects and taking products to market.
This expertise allows us to offer product performance testing to ISO 7198 (Cardiovascular implants and extracorporeal systems) and ISO 10555 (Intravascular catheters).
Working within the constraints of our quality system ensures customers always receive comprehensive reports and test results.

Lucy Petersen, QA & RA Manager, Vascular Flow Technologies

QA & RA Manager

Lucy Petersen

Lucy joined Vascular Flow Technologies in January 2020 bringing with her knowledge and experience in quality and research and development gained in medical device manufacturing. Lucy also has experience in biocompatibility and toxicology as well as working with regulatory agencies e.g US FDA.
Lucy has a BSc in Chemistry from Aberdeen University.

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