The UniSafe is a springless, passive safety device for pre-fillable syringes.
With more than 65 years of experience in medical devices, Owen Mumford Pharmaceutical Services, a division of Owen Mumford, is located in Woodstock, UK, specialising in the design, development and manufacture of injectable drug delivery systems across pharmaceutical, biotech and generics industries.
Our trusted devices are used across the globe in the delivery of medications for a range of conditions.
Our presence is global and spans from manufacturing facilities in the UK and Malaysia to subsidiaries in the US, Germany and France.
Devices for drug delivery
Our innovative products include single and multi-dose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration.
Owen Mumford Pharmaceutical Services
These are designed and known for their ease of use, simplicity and improved safety and patient compliance, meeting the needs of both our pharmaceutical partners and their patients.
Platform and custom injectable drug delivery systems
With an established history of developing world-leading custom devices, we have recently extended our capabilities to include a range of platform products. We continue to pride ourselves on our expertise, support and personal offering; designing products with patient needs at the forefront of the mind and simplifying our partners’ combination product development process.
UniSafe® pre-filled safety syringe
A simple, spring-free pre-filled safety syringe for use with 1mL primary containers, UniSafe has an integrated safety mechanism that helps to prevent needlestick injuries and complies with safer sharps regulations. UniSafe is a passive safety device whereby needle retraction and shielding is automatically activated when the user has fully depressed the plunger and finished their injection using a normal injection technique. It has a minimal component count and is designed to work with ISO standard pre-filled syringes. The lack of spring means there is no risk of pre-activation during transportation.
UniSafe platform for injectable drug delivery systems
The UniSafe platform is developed around the already commercially available UniSafe 1mL device.
UniSafe 2.25 for larger medication volumes will be available during 2020 and in development currently is also a reusable Auto-Injector, which will offer the option of connectivity.
Our products are supported by our services, working with our partners every step of the way to support and guide them from initial concept through to taking the solution to the market.
With over 50 product registrations to date, we have experience in dealing with the FDA, EMA and other regulatory bodies. In addition to this, we have gained expertise in the regulatory complexities associated with combination products over a period of many years.
Using this knowledge, we can guide the regulatory application processes by providing the necessary data, documentation & guidance to help you achieve a positive outcome.
Our management system is set up to ensure we are fully compliant with medical device regulations such as 21 CFR 820, ISO 13485:2016 and forthcoming MDR (medical device regulation) as well as ensuring adherence to GMP (Good Manufacturing Practise).
Our quality ethos across the organisation helps us ensure that all of our devices meet the rigorous standards that apply to the device, pharmaceutical and biotech industries.
Our primary objective is to ensure that the final device is safe and effective for use by a diverse range of users. Usability is key to success throughout both the product development & design process. Our human factors process is fully compliant with regulatory requirements, and we conduct user evaluation planning to provide comprehensive study data to support your product registration process.
We produce billions of components and assemble hundreds of millions of life-changing devices each year through our manufacturing and packaging operations in the UK, US and Asia.
Cur capabilities include manual and semi-automatic assembly, flexible manufacturing and fully automated production. Our cleanroom facilities can also be utilised for manufacturing, processing and packaging when required, accommodating all our customers’ needs.
Our pharmaceutical industry customers, innovation and technical expertise are key to our success. With a long history of providing a range of devices, our research and development department provides the critical expertise for creating products that help patients to improve their disease management.
We start this process by acquiring an in-depth understanding of patient and healthcare practitioners’ needs and the challenges they face during drug administration.
Specialising in the design, development and manufacture of injectable drug delivery systems across pharmaceutical, biotech and generics industries, Owen Mumford's trusted devices are used across the globe in the delivery of medications for a range of
From day one, we will guide you throughout the development process; at every step, you will benefit from professional and supportive project management, processes, industrialisation and production for smooth development and launch.
Owen Mumford has unveiled a new addition to its range of medical devices at PDA: The Universe of Pre-Filled Syringes and Injection Devices event in Vienna.
Owen Mumford has unveiled a new addition to its range of automatic injection devices at the CPHI event in Paris.