GHP Q2 2022

22 GHP Q2 2022 Irwin & Associates has been providing consulting service support to the medical device and biotechnology spaces for the last 22 years. The firm has focused in the main areas of Quality, Regulatory, Project Management, Design Control, Technical Writing, R&D, Software, and Clinical Education. Recognised in this issue of Global Health & Pharma as the Best Medical Device Consultancy Services Company, 2022 – USA, we will take a closer look at the company. Irwin & Associates has remained a key player in Medical Device industry as they have the expertise and flexibility to support very small start-up companies directly at product conception all the way up to major biotechnology companies of 5,000+ employees. Each client’s project is approached by a subject matter expert in their field, with their experience stemming from decades of work in the medical device/biotech industries and supported by staying up-todate on the latest regulatory standards and emerging technologies. Underlying Irwin & Associates’ work are the core values of providing top-notch service for each project with expertise, integrity, and the highest standards of quality. These go alongside its internal core values of onboarding exceptional consultants and matching them with a client and project that interests them and grows the engineer or scientist professionally. Irwin & Associates is unique in that its team is singularly run by the firm president and owner, Barbara Allen, who is also an active consultant. She runs the firm very lean and efficient, which allows the providing of competitive quotes for clients while at the same time providing a more team-like environment for the on-staff consultants. When bringing new consultants on board, the company looks for subject matter experts in their particular area of service with a proven record of engineering and scientific excellence. Barbara commented, “Irwin & Associates is passionate about providing flexible and part-time work options for consultants looking to create a schedule that fits their works/life balance at each stage of life. At the same time, we are proud of the important and lifesaving work that our consultants are completing for their clients to further technology development in robotic surgery, diabetes, cancer treatment, cardiology, and neurovascular treatment, just to name a few.” Over the last 22 years, the firm has grown and expanded while maintaining its core values as a team. And during the pandemic, it was able to pivot to almost entirely remote support for a period of time, opening up additional clients across the country and the world. Ultimately, Irwin & Associates’ clients can’t say enough positive things about it, one client commented, “Consultants from Irwin & Associates are the BEST talent you can get out there. If you want agility and high quality results, I cannot recommend them enough. They are able to fold seamlessly into any organisation and deliver exactly what the project team needs and more.” Another client shared, “I have had numerous engagements with Irwin & Associates over the last few years related to quality, manufacturing, and regulatory. All their consultants have been consummate professionals that have immediately brought invaluable expertise. Barbara is an absolute pleasure to work with and I highly recommend Irvin & Associates to anyone in the medical device industry.” Company: Irwin & Associates, Inc. Contact: Barbara Allen Email: [email protected] Website: Medical Device Consulting Firm Placing Excellence First Mar22642