Arrotek

Medical device regulations are complex. They are also regularly updated and refined. So, rather than being a fixed set of rules, they constantly evolve. Therefore, it’s essential to have access to medical device regulatory experience and expertise during the application process. Third-party regulatory support can be beneficial for companies of any size, but it is … 4 Tips for Choosing a Medical Device Regulatory Consultant

Your medical device start-up has fantastic potential, but it’s essential to make the right decisions today to maximise its value in the future and make it attractive to investors and/or potential buyers. That means finding the right partners to progress your idea. Running a start-up medical device company is an exciting but often very busy … How Arrotek Adds Value to Your Medical Device Start-Up Company

By Richard McLoughlin Bringing a new medical device product to market is an intensive and extensive process, so it’s important you get the right support. The best approach is to work with a partner that offers a complete service offering, with end-to-end support from the concept development stage through to full-scale manufacturing. At Arrotek, we … Medical Device Design Services – Support from Concept to Full-Scale Production

By Paula Johnson While fine needle aspiration (FNA) and fine needle biopsy (FNB) are common procedures for the diagnosis of cancer, there is no specific device option that is the best choice in all situations. In fact, there is a large range of design and feature options available in both the FNA and FNB categories … Choosing the Right Fine Needle Aspiration or Fine Needle Biopsy Device

Design transfer is a phrase that describes the activities and processes that introduce a medical device design to production. Effective design transfer is required by regulators but it also keeps manufacturing costs under control and ensures production milestones and deadlines are met. Furthermore, effective design transfer can reduce time to market and improve product quality. What … Three-Phase Design Transfer Process to Prepare a Design for Manufacturing

Our modular approach to the delivery of medical device design and development services means we can help with whatever level of support you need, whatever expertise you need, and wherever you are in the development process. While there are similarities across all medical device design and development projects, our experience at Arrotek is that every … Arrotek’s Modular Approach to Medical Device Design and Development Services

It is now over a year since the new EU Medical Device Regulation (MDR) came into effect. Whether you are an early-stage start-up, a company further advanced in your start-up journey, or an established medical device company, what are the current realities of EU MDR compliance? The fact is, there are challenges that will impact … Bottlenecks, Timelines, and Complexity: Overcoming EU MDR Challenges