A question we are often asked at Arrotek is how long it takes to design a new medical device product. Knowing this helps entrepreneurs and businesses plan future steps, including those that come after the product is designed, including putting the product through clinical trials. The problem with answering the question of how long medical … How Long Does It Take to Design a New Medical Device Product?
The best approach to developing a new medical device product is to use an iterative design process. Iterative design is a methodology used to create products in all industries, from physical products to software. What is iterative design, however, and what are the benefits? What is Iterative Design? Iterative design involves the development of a … Benefits of an Iterative Design Process
Press Release 1 August 2019 Arrotek, the Sligo-based medical device specialist, has completed its move to a new purpose-built facility that includes significantly expanded cleanroom production capacity. Arrotek specialises in bridging the gap between an idea or concept for a new medical device and bringing that medical device to market. Its expertise includes designing, developing, … Press Release: Sligo-Based Medical Device Specialist Arrotek Doubles Its Cleanroom Production Facilities
To sell a medical device product in the US, you need approval from the FDA (the Food and Drug Administration). A key part of getting FDA approval is the classification of your medical device. Not only will the classification determine much of the design and development process, it will also determine what is required to … FDA Medical Device Classifications Explained
Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system. … EU Medical Device Classifications Explained
Design controls are essential to ensuring your medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product. What are design controls? Design controls are part of … Quality Systems and Design Controls in the New Medical Device Development Process
We would like to remind everyone that Arrotek will be moving premises next week! Our new purpose-built facility in Finisklin is looking great and we can’t wait to get moving. Please note that due to the move, our phone and internet lines may be down between Wednesday the 26th June to Wednesday 3rd July. As … Moving premises
While each new medical device product design and development project is different, the process followed is typically well-structured. There are many reasons for this, not least the importance of ensuring the product is safe to use as well as ensuring both the product itself and the design process adheres to medical device regulations. At Arrotek, … An Overview of the Medical Device Design and Product Development Process
GALT ACQUIRES ARROTEK MEDICAL Combination of Arrotek’s Product Development with Galt’s Manufacturing Capabilities will Benefit Customers and Provide Access to New Segments of the Interventional Market GARLAND, TX – May 20, 2019 – Galt Medical, a subsidiary of Theragenics Corporation® and a global supplier of access and procedure products for a range of interventional and … GALT ACQUIRES ARROTEK MEDICAL
Turning an idea for a new medical device into a product that is ready for testing and evaluation is a complex process, particularly if you have never been through it before. This overview of the medical device design and development process will outline the things you and your design/development team will consider. In the next … Considerations that Inform and Guide the Medical Device Product Design Process
