22 GHP / Q3 2021 GHP / Q3 2021 23 , , Jun21445 Jun21428 Irwin & Associates Inc. has made itself one of the ‘Best Medical Device Consultancy Services Company’ by leaps and bounds in 2021 for the USA, working with clients across all manner of scales and operational goals. In essence, its support guarantees the betterment of a client’s company across the board, from its regulatory compliance to its quality systemor manufacturing processes, whether they are a start-up company or a well-established giant of enterprise. Located in the San Francisco bay area, Irwin & Associates is the consulting firm supporting the medical device and biotechnology industries with exemplary advice and comprehensive support. Fundamentally, its top-of-the- range team is made up of subject matter experts in the areas of quality control, regulatory and legislative advice, manufacturing, engineering, technical writing, R&D, project management, design control, and software, making it a one-stop-shop for its medical device producing clients. It also brings itself significant notoriety and good repute with its work specifically focusing on small start-up company culture, particularly adapt at working with these clients in order to ensure they make quick and efficient progress on their flagship products, helping them reach their goals. Additionally, Irwin & Associates is experienced in the support of mid-to-large sized companies, taking on key projects for such clients in order to allow them to launch new products or quickly acquire smaller companies. In essence, its work can be beneficial for all scales of company, no matter where a client The Support System Behind the USA’s Medical Technology Boom is in their business’s lifespan. Above all else – and showing the value it puts on its relationships with its consultants and clients both – the firm is always looking towards working with synergy and effectiveness, championing working together in order to find greater levels of success. Irwin & Associates adeptly supports domestic and international clients at all stages of development, manufacture, and regulation, earning it a wide depth and breadth of experience and forming a truly outstanding portfolio of past successes throughout its 21 years of operation. With excellent service, top notch engineers, and incredible scientific minds, its consultancy has made itself a support system like no other. Additionally, its office is staffed by anywhere between 8-20 consultants at any one time, ensuring that its close-knit team of experienced medical device professionals and experts work well together , something that has resulted in a team of people that are familiar with each other’s work from previous jobs. It is this that makes for the outstanding and friendly environment that Irwin & Associates has become known for alongside the excellence of its work. When a new client begins a project with Irwin & Associates, Award Winning Mobility Solutions from Rehasense Rehasense is a global company with Danish roots that specialises in innovative high-quality products for the rehabilitation market with a strong focus on safety, design and functionality. The Rehasense product range includes mobility aids such as rollators and wheelchairs along with additional mobility solutions and its European regional executive offices are located in Denmark and Germany, with the customer services and logistics hub based in Poland. The ICON 35 wheelchairs sit perfectly within Rehasense’ s growing product portfolio. Weighing only 8.2kg, the ICON 35 BX is the lightest wheelchair in the ICON range and features an ergonomic seat and back angle to provide a superb seating position. Weighing only 9.0kg, the ICON 35 LX is fitted with enhanced ergonomic seating, back upholstery and adjustable arm rests for increased levels of support and pressure relief if required. Both models have seat widths of 16”/40cm and 18”/45cm respectably and for transportation and storage can be easily folded and take up little space with length, height and width dimensions of just 26”x29”x11”. With a maximum user weight of 125kg both models offer a great lightweight wheelchair solution suitable for most users. Standard features on the ICON 35 BX and LX include swing away leg rests with release lever, stepwise brake control with cable, armrest (height adjustable on the LX) and carrying handle for transporting when folded. One of the latest additions to the ever-growing Rehasense product portfolio is the TRACK WHEEL which is the lightest front wheel attachment currently available. The TRACK WHEEL has been designed to transform a standard manual wheelchair into an agile tricycle to enable wheelchair users to experience greater freedom. Whether you are out and about around town, or going for more adventurous days out over rougher terrain such as in the forest or on the beach, the TRACK WHEEL is the ideal companion. By attaching the 12” TRACK WHEEL, the wheelchair’s castors are raised which slightly tilts the chair backwards and by noticeably reducing the rolling resistance, the user can enjoy increased speed, manoeuvrability and comfort. Weighing from only 2.6 kg and currently available in single arm carbon and later this year in double arm aluminium or carbon, the TRACK WHEEL adds very little weight to the existing wheelchair. The single arm model has been designed for use with rigid wheelchairs while the double arm model will be for use with foldable wheelchairs featuring fixed integrated footrests. Attaching the TRACK WHEEL to the they can immediately benefit from an expert Consultant ready to make quick progress which ensures their medical device company is well prepared for a bright future. Although Covid-19 posed some challenges to Irwin & Associates and companies like it as it was harder than ever to meet up face to face with clients, it worked hard to make the pivot happen, implementing technological platforms in order to ensure it could keep in contact with its team and its clients. In essence, as a group, it made itself more flexible than ever in order to take the pandemic in its stride. This was what has allowed Irwin & Associates to keep working throughout the outbreak and to continually support its clients, something that has resulted in taking on more start-up companies and see an increase in the growth of new technologies and projects. It does not forecast this development slowing down anytime soon, excited to see what projects it will be taking on next, and promising to take both its staff and its clients forward into the future of medical technology. Company: Irwin & Associates, Inc. Contact: Barbara Allen Website: irwinassociatesinc.com wheelchair frame requires no tools and the entire process takes a matter of seconds. For people looking to add extra power to their wheelchair, the Power Assisted Wheelchair Systems (PAWS) from Rehasense is perfect and combines superb ergonomic design and functionality. There are three models available: the Cruiser, City and Tourer which, when fully charged, can provide a range of up to 40km depending on terrain, user weight and model chosen. The City has a 12” or 14” wheel and is designed primarily for use around town, while the Cruiser has a larger 16” wheel for rougher terrain. The off-road Tourer has a 20” wheel and 4” fat tyre for increased clearance and manoeuvrability. PAWS comes with the option of manual or automatic clamping and requires no frame alteration or additional add-ons to the wheelchair. You can view the full range of Rehasense products at www. rehasense.co.uk (UK market) and www.rehasense.com (for all other markets). For UK enquiries, contact Lee French on 0333 220 0704 email
[email protected] For overseas enquiries, contact Rebecca Graber on +49 176 - 344 332 76, email rebecca.
[email protected]