About Omsbar
Omsbar provides technical and hard-to-find services to medical device organisations.
We have worked with a range of clients, from start-ups requiring expert input on getting their new product to market, through to established organisations requiring third-party auditing or validation services
Company history
Omsbar was founded in Oxfordshire in 1989 with the express aim of providing experienced and expert technical services to the medical device industry, the founders having met and worked as colleagues in the early 1980’s at Oxford Medical Systems. Until 2000, Omsbar was run on a part-time basis providing medical device design and manufacturing services. In 2000, the other founders were bought out by Tony Thorne, one of the original founders, and Omsbar then became a full time organisation. Tony decided to provide a service based on expert and in-depth practical knowledge of medical device design, manufacturing and regulatory affairs.
in 1996 started to impose formal legal requirements on medical device organisations operating in Europe. These requirements have become more comprehensive and more stringent over the years and now possibly represent an obstacle to the expansion aims of SME’s and to the establishment of start-up organisations with new ideas and new technology. Tony has worked throughout this period of increasing legislation and regulation as an engineer and regulatory affairs specialist. Work colleagues throughout this period have subsequently joined Omsbar and provide a comprehensive skill set with in-depth knowledge and experience.
The set of requirements for a Technical File, Design Dossier or 510(k) are listed in the legislation, international standards and guidance documents. Omsbar adopts an an engineering approach to regulatory affairs in order to identify all the requirements necessary as deliverables to the regulatory authorities and then plan the project to deliver them. The project then aims to provide and validate the deliverables.
It seems self-evident that anyone can do this but in our experience, companies tend to ignore these requirements during the developmental stage because they appear complex and prohibitively onerous. Once it is realised that not only will the requirements not go away but that they are also an obstacle to achieving product registrations, it is often too late in budgetary terms and timescale to do anything effective about it. It is far better to plan for these requirements at the outset when their implementation can be achieved more easily, quickly and cost-effectively.
If you plan this way, you end up with a project plan and a lot of deliverables. Omsbar, with its in-house resource can provide these deliverables, it is difficult for instance to find organisations that can determine biocompatibility validation, IEC 60601 compliant design, injection moulding services and safety critical & mission critical software together with an understanding of how they must all fit together. Anyone can tell you, for instance, that as an organisation, you must perform risk-analysis and incorporate principles of usability into your products. Not only does Omsbar tell you these things; it also provides the services, facilities and expertise to deliver these requirements.
Omsbar is a small organisation but this allows us to be both responsive and flexible. We can tailor our services to your exact requirements and since our resources are mostly in-house and under our direct control, we can respond to urgent requests for assistance in a more positive way. Talking to us means that you can talk to experienced people who actually provide the services, rather than to a sales person or office administrator.
Product development
Because we are engineers, we also can input technically to your projects and indeed, we are named inventors on several client projects. IP of course is the property of the client and we have insight into the value of such IP and what it means to the viability of a project.
Associated with this work is a thorough knowledge and experience of getting products into market and obtaining regulatory approvals.
Michael has a background of production engineering and manufacturing in the medical device industry and has a lot of quality management system and regulatory affairs experience. He provides first-hand expertise in implementing, managing and sustaining global quality management systems for clients.
Chris provides the skill, experience and expertise to produce prototype devices, production tools and test equipment for clients. These range from go/no go gauges through to software controlled electro-pneumatic assembly jigs. Working prototypes and models are also produced using a variety of manufacturing and fabrication methods.
Dave provides the software services. These are principally embedded, usually in C/C++ and PC applications using C#. Projects range from simple production test aids through to life sustaining and image capture/processing.
We hope this web-site gives you an idea of the services we provide and the resources and facilities at our disposal. Please give us a call or
if you would like to talk in confidence about a project or service that we can provide. We will be delighted to hear from you.
Omsbar Ltd, Upper Office, Building A, Lower Broadway, Didcot, OX11 8ET, UK | Tel +44 (0) 1235 814 680 | Email:
Company No 2393082 | Incorporated in England 1989 | Registered Office 5 The Chambers Vineyard Abingdon Oxfordshire OX14 3HH
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