Regulatory Testing
Mechanical Testing
Accentus Medical has many years of in-house experience at establishing mechanical test data protocols for orthopaedic implants that are designed to meet regulatory requirements, either as part of a design process, or to satisfy customer demands. All results are confidential, unless otherwise specified, and are delivered in a timely and cost effective manner.
Mechanical Testing – setting the standard
All testing is performed in a testing facility with ISO 13485 certified procedures, meeting the requirements of ISO, ASTM, and US FDA. Our Orthopaedic implant testing facility incorporates computer-controlled systems, which enables us to perform many different testing programmes for a wide range of implant designs and materials. The range of mechanical testing services include:
- Single static tension/compression and shear
- Strain-life fatigue testing in tension/compression
- Surface engineering, roughness and abrasion.
Analytical studies – fit for purpose
Examples of analytical testing performed:
- Study of implant surfaces (including coating thickness / porosity) using scanning electron microscopy and associated analysis
- Study of implant coatings utilising X-ray diffraction techniques.
ISO Certificate
Accentus Medical is certified by Lloyd’s Register to the ISO13485:2016 standard, applicable to the following scope:
- Surface coating and treatment of medical implant devices.
- Research and development, evaluation and associated testing of orthopaedic devices.
- Research and development and technical services related to surface engineering.
The ISO13485 certification is designed to ensure that our quality management system ensures safe and effective outputs from our manufacturing and R&D services.
Our ISO 13485:2016 compliant system provides reassurance to our customers that they can have confidence in the quality and reliability of our product and services.
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About Accentus Medical
Accentus Medical is a leading medical technology company that combines over 20 years of expertise in commercial supply of clinically proven surface coating and modification technologies, with dedicated research and development of new technologies for the medical device industry. The Accentus Medical team is renowned for its scientific expertise, medical device experience and track record for responsive, high quality service.
Our Acusure® range of surface coatings are designed to improve both biocompatibility and durability of orthopaedic and certain other implantable medical devices. The Acusure® range includes a series of thermal plasma sprayed Hydroxyapatite and Titanium metallic coatings that have been in worldwide clinical usage for more than 20 years.
The company is also pioneering the commercial application of innovative and proprietary medical device surface treatments incorporating silver ions, to produce antimicrobial surfaces designed to reduce the risk of near-term post-operative infection. The Agluna® surface technology incorporates antimicrobial silver ions into the surface of titanium and titanium alloy implantable medical devices. Agluna® has undergone successful clinical application since 2006 in the field of custom-made and modular tumour replacement prostheses, and is being adopted across an expanding range of limb salvage and complex revision devices. The technology also has potential to assist in prevention of post-operative infection across a range of implantable device sectors. The company has also developed its proprietary Acusure Ag® coating incorporating silver ions into plasma sprayed hydroxyapatite coatings.
In addition to in-house research and development activities, Accentus Medical works collaboratively with major orthopaedic and medical device manufacturers, on a global basis, to develop and supply novel surface treatments and coatings.
The company is also a recognised supplier of medical device regulatory testing services, and manufacturers have repeatedly included test results generated by Accentus Medical’s in-house laboratories for many years, in their medical device file approval submissions.
History
Accentus Medical has its foundations in the research laboratories of the United Kingdom Atomic Energy Authority (UKAEA), located at the Harwell Campus, south of Oxford. The leading UK Medtech innovation hub remains the home of Accentus Medical, together with the historically renowned Rutherford Appleton Laboratory and the internationally recognised Diamond Synchrotron.
Pioneering coating techniques for orthopaedic implants
The UKAEA first became involved in the field of orthopaedics in the 1970s when many orthopaedic manufacturers were searching for processes to improve the strength, wear-resistance and biocompatibility of the metallic alloys used in their implants. As part of the research into nuclear reactor design, many coating techniques such as thermal plasma spraying, ion implantation, and titanium nitride surface enhancement were discovered and developed at Harwell and then adopted by numerous orthopaedic companies. For example, plasma spray metallic and hydroxyapatite coatings are now used globally in cementless total joint prostheses.
Considerable expertise in other areas relevant to orthopaedic science was also available at Harwell. This included failure mode analysis, fatigue testing of metallic artefacts and corrosion studies. As a result the Harwell site rapidly became the leading UK centre for the regulatory testing of joint replacement products and was involved in the initial drafting of numerous British and ISO standards covering the testing of orthopaedic devices and the specification of medical grade alloys.
Leading supplier of Acusure® and Agluna® coating technologies
Today, Accentus Medical is an established world-leading independent supplier to the global orthopaedic industry of its Acusure® range of inert/reducing gas plasma spray coatings, and pioneering Agluna® and Acusure Ag®® silver ion based antimicrobial surface technologies. The company also continues to conduct regulatory testing for major orthopaedic implant manufacturers.
Innovative research and development of orthopaedic implants and other medical devices
Accentus Medical has its own well established research and development group, involved in the development of intellectual property in the medical device area. With a track record in development and commercialisation of its proprietary coating technologies, the company continues to undertake innovative coating developments targeted towards continuing improvement in patient outcomes in its target clinical applications.
Ensuring Ethical Integrity: Our Policies
On this page, you will find a comprehensive overview of our policies on Anti-Bribery, Anti-Corruption, Anti-Slavery, and Fraudulent Activity. These documents outline our commitment to ethical practices and our stance against illegal activities within the organization. Each policy details the standards we uphold and the measures we take to ensure compliance and integrity in all our operations. Please review the documents below for more detailed information on our policies and how they are implemented across the company.
Anti-bribery and corruption policy
Anti-slavery policy
Fraudulent activity policy