Bringing Manufacturing Home to the UK


Mike Thornton 

“SI is committed to ‘bringing manufacturing home to the UK’ and has invested substantially in the manufacturing facilities to ensure that this philosophy is realised. It is this that gives us an edge in the medical device industry as we have the ability to be in control of the high quality that is expected of our products. The strength of SI lies within the people who work here, their skill, commitment and determination allow us to achieve our goals.

Care is taken throughout the entire production process to ensure that SI’s medical devices are manufactured to meet exacting quality standards. Our validated processes also give us reliability for high volume manufacturing of products; however we still have the ability to be flexible to rapidly respond to all of our customer requirements. We manufacture our own successful brand of products with our Resposable® concept, combining both reusable and disposable components, which are at the forefront of our vision for ultimate quality and best value.”

We understand the positive impact the younger generation has to offer and so we are dedicated to running a proactive apprenticeship scheme to nurture this young talent. Our apprentices undertake training in all areas of the business such as quality, inspection, product development engineering, machine shop, assembly, and injection moulding allowing them to gain the wide-ranging practical skills required in the specialist manufacturing industry. The scheme gives SI the opportunity to train apprentices to our company standards alongside industrial standards thereby helping towards combatting the skills shortage in the manufacturing industry. I am proud that we were recently awarded Medium Employer of the Year at the Leeds Apprenticeship Recognition Awards.”

 

Mike Thornton, Chief Financial Officer

 

 

Facilities

Manufacturing facilitiesOf the 32,000 sq ft premises, 24,000 sq ft is assigned to manufacturing, assembly and warehouse emphasising the importance attributed to this area of the business.

The machine shop houses top of the range machinery including:

  • A selection of Citizen sliding head machines
  • Miyano Citizen fixed head machines
  • Willimen machinery
  • Haas machinery range
  • Jones and Shipman grinding machines
  • Selection of pneumatic and electric presses
  • Rapid prototyping facilities
  • Laser welding and laser marking
  • Product cleaning lines
  • Fanuc all electric injection moulding machine - clean room moulding capabilities
  • CMM machines including Mititoya and Vision systems
  • Various inspection equipment

The cleanrooms are class 7 and class 8, purpose-built for the requirements of SI’s product assembly lines.

 

 

Quality

Surgical Innovations (SI) operates in accordance with the following regulations and standards:

  • The European Medical Device Directive 93/42/EEC
  • The U.S. Medical Device Quality Systems Regulations (QSR)
  • SOR/98-282 Canadian Medical Device Regulation (MDR) - assessed in accordance with the Canadian Medical Devices Conformity Assessment System (CMDCAS) as conforming to the requirements of ISO 13485-2003
  • The Quality Management Standards EN ISO 13485:2012 and ISO 9001:2008

We have an established quality management system, applicable to the design, manufacture and inspection of products which is certified to ISO 13485:2003 and ISO 9001:2008. This is managed by a dedicated team of quality engineers who collaborate with all areas of the business in the interest of patient safety and customer satisfaction to ensure the quality of products and services.

 

Quality Certification

Please click on the links below to view all of our ISO 13485 and ISO 9001 Quality Management Certificates.

ISO 9001: 2008 Surgical Innovations Ltd 

ISO 13485 Surgical Innovations Ltd (CMDCAS)

EN ISO 13485:2012 Surgical Innovations Ltd 

EN ISO 13485 :2012 Haemocell Ltd 

ISO 9001: 2008 Haemocell Ltd